USER INTERFACE FOR EXTERNAL CHARGER FOR IMPLANTABLE MEDICAL DEVICE

Description

FIELD OF THE INVENTION

[0001] This invention relates to implantable medical device systems including energy transfer devices for implantable medical devices.

BACKGROUND OF THE INVENTION

[0002] Implantable medical devices for producing a therapeutic result in a patient are well known. Examples of such implantable medical devices include implantable drug infusion pumps, implantable neurostimulators, implantable cardioverters, implantable cardiac pacemakers, implantable defibrillators and cochlear implants. Of course, it is recognized that other implantable medical devices are envisioned which utilize energy delivered or transferred from an external device.

[0003] A common element in all of these implantable medical devices is the need for electrical power in the implanted medical device. The implanted medical device requires electrical power to perform its therapeutic function whether it be driving an electrical infusion pump, providing an electrical neurostimulation pulse or providing an electrical cardiac stimulation pulse. This electrical power is derived from a power source.

[0004] Typically, a power source for an implantable medical device can take one of two forms. The first form utilizes an external power source that transcutaneously delivers energy via wires or radio frequency energy. Having electrical wires which perforate the skin is disadvantageous due, in part, to the risk of infection. Further, continuously coupling patients to an external power for therapy is, at least, a large inconvenience. The second form utilizes single cell batteries as the source of energy of the implantable medical device. This can be effective for low power applications, such as pacing devices. However, such single cell batteries usually do not supply the lasting power required to perform new therapies in newer implantable medical devices. In some cases, such as an implantable artificial heart, a single cell battery might last the patient only a few hours. In other, less extreme cases, a single cell unit might expel all or nearly all of its energy in less than a year. This is not desirable due to the need to explant and re-implant the implantable medical device or a portion of the device. One solution is for electrical power to be transcutaneously transferred through the use of inductive coupling. Such electrical power or energy can optionally be stored in a rechargeable battery. In this form, an internal power source, such as a battery, can be used for direct electrical power to the implanted medical device. When the battery has expended, or nearly expended, its capacity, the battery can be recharged transcutaneously, via inductive coupling from an external power source temporarily positioned on the surface of the skin.

[0005] Transcutaneous energy transfer through the use of inductive coupling involves the placement of two coils positioned in close proximity to each other on opposite sides of the cutaneous boundary. The internal coil, or secondary coil, is part of or otherwise electrically associated with the implanted medical device. The external coil, or primary coil, is associated with the external power source or external charger, or recharger. The primary coil is driven with an alternating current. A current is induced in the secondary coil through inductive coupling. This current can then be used to power the implanted medical device or to charge, or recharge, an internal power source, or a combination of the two.

[0006] Since it may be necessary for the patient to operate the external power source and since the patient may not be medically skilled nor electronically skilled, it is desirable that the external power source have a user interface that is both intuitive and simple to use and operate.

[0007] US 5,735,887, US 5,591,217, US 4,232,679 and US 6,381,496 are all concerned with providing power to an implantable device. A system according to the first part of claim 1 is known from US2003/0120323A1,

[0008] The present invention provides an implantable medical device system as defined in claim 1.

[0009] In a preferred embodiment, at least one of the display icons is an icon representative of a state of charging of an energy storage device in the implantable medical device.

[0010] In a preferred embodiment, at least one of the patient controls is a control for adjusting the therapeutic output of the implantable medical device.

[0011] In a preferred embodiment, the external energy transfer unit inductively couples energy to the implantable medical device.

[0012] In a preferred embodiment, the implantable medical device has a rechargeable energy storage device and wherein the energy transfer unit charges the rechargeable energy storage device.

[0013] In another aspect, the present invention provides an implantable medical device system. An implantable medical device provides a therapeutic output to a patient. An external energy transfer unit can be operatively coupled to transcutaneously transfer energy to the implantable medical device. The energy transfer unit is operable by the patient with less than three operative controls to control energy transfer from the external energy transfer unit to the implantable medical device.

[0014] In another embodiment, less than three operative controls control energy transfer from the external energy transfer unit to the implantable medical device.

[0015] In a preferred embodiment, the energy transfer unit is operable with two operative controls to control energy transfer from the external energy transfer unit to the implantable medical device.

[0016] In a preferred embodiment, the two operative controls comprise a start control and a stop control.

[0017] In a preferred embodiment, the start control is a start button and wherein the stop control is a stop button.

[0018] In a preferred embodiment, the energy transfer unit also has operative controls to start and stop the therapeutic output of the implantable medical device.

[0019] In a preferred embodiment, the energy transfer unit also has a control to enable and silence audio feedback from the energy transfer unit.

[0020] In a preferred embodiment, the external energy transfer unit inductively couples energy to the implantable medical device.

[0021] In a preferred embodiment, the implantable medical device has a rechargeable energy storage device and wherein the energy transfer unit charges the rechargeable energy storage device.

[0022] In another embodiment, the implantable medical device is capable of receiving inductively coupled energy with a secondary coil and is capable of being transcutaneously controlled using an internal telemetry coil. An external antenna has a primary coil adapted to inductively transfer energy to the secondary coil of the implantable medical device when the external antenna is externally placed in proximity of the secondary coil. An external energy transfer unit is adapted to be operatively coupled by a cord to the external antenna driving the primary coil to inductively transfer energy to the implantable medical device. The energy transfer unit has an external telemetry coil allowing the energy transfer unit to communicate with the implantable medical device through the internal telemetry coil in order to at least partially control the therapeutic output of the implantable medical device.

[0023] In a preferred embodiment, the inductively transferring step and the communicating step occur simultaneously.
In a preferred embodiment, the energy transfer unit can control the implantable medical device to turn the therapeutic output on and off.
In a preferred embodiment, the energy transfer unit can control the implantable medical device using the external telemetry coil while transferring energy to the implantable medical using the primary coil of the antenna.
In a preferred embodiment, the implantable medical device has a rechargeable energy storage device and wherein the energy transfer unit charges the rechargeable energy

[0024] storage device.

[0025] Preferred embodiments will now be described, by way of example only, with reference to the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 is a block diagram of an external programmer and an external charging device for an implantable medical device such as can be utilized in the present invention;

[0027] Figure 2 is a detailed block diagram of an implantable medical device implanted subcutaneously and an associated external charging device in accordance with an embodiment of the present invention;

[0028] Figure 3 illustrates the start-up flow of an external programmer usable in conjunction with an implantable medical device;

[0029] Figure 4 illustrates operation flow of an external programmer usable in conjunction with an implantable medical device;

[0030] Figure 5 illustrates a therapy status screen of an external programmer;

[0031] Figure 6 illustrates access to menu selection of an external programmer;

[0032] Figure 7 illustrate group selections of an external programmer;

[0033] Figure 8 illustrate parameter selections of an external programmer;

[0034] Figure 9A illustrate screens of an external programmer;

[0035] Figure 9B illustrate messages of an external programmer;

[0036] Figure 9C illustrate warnings of an external programmer;

[0037] Figure 10 illustrate menu selections of an external programmer;

[0038] Figure 11 illustrates audio status of an external programmer;

[0039] Figure 12 illustrates contrast of an external programmer;

[0040] Figure 13 illustrates INS/ENS time of an external programmer;

[0041] Figure 14 illustrate time / number formats of an external programmer;

[0042] Figure 15 illustrate patient programmer information;

[0043] Figure 16 illustrates INS/ENS information;

[0044] Figure 16A illustrates Telemetry N information:

[0045] Figure 17 illustrates the navigation flow of an external charger for recharging the INS;

[0046] Figure 18 illustrates the navigation flow of an external charger for recharging the external power source;

[0047] Figure 19 illustrates screen shots of charge status of an external charger;

[0048] Figure 20 illustrates status messages displayed during charging of the INS;

[0049] Figure 21 illustrates external power source charge status screens;

[0050] Figure 22 illustrates status messages displayed during recharging of the external power source; and

[0051] Figures 23A and 23B illustrate screens, information messages and warnings.

DETAILED DESCRIPTION OF THE INVENTION

[0052] In Figure 1, external programming unit 2 is attachable via cord 4 to an external telemetry coil 6. External programming unit 2 can program operations of implantable medical device 16 (Figure 2) in a conventional manner using external telemetry coil 6. External antenna 52 is attachable via cord 56 to external charging device 48 to inductively transfer power to implantable medical device 16 when external antenna 52 is placed in proximity of a secondary coil 24 associated with implantable medical device 16. External charging device 48 receives AC power from cord 8 through transformer 10. External antenna 52 can be held in position on patient 18 with belt 12.

[0053] Figure 2 illustrates an embodiment of implantable medical device 16 situated under cutaneous boundary 38. Charging regulation and therapy control is conventional. Implantable medical device 16 also has internal telemetry coil 44 configured in conventional manner to communicate through external telemetry coil 46 to an external programming device 2, charging unit 50 or other device in a conventional manner in order to both program and control implantable medical device and to externally obtain information from implantable medical device 16 once implantable medical device has been implanted. Internal telemetry coil 44, rectangular in shape with dimensions of 1.85 inches (4.7 centimeters) by 1.89 inches (4.8 centimeters) constructed from 150 turns of 43 AWG wire, is sized to be larger than the diameter of secondary charging coil 34. Secondary coil 34 is constructed with 182 turns of 30 AWG wire with an inside diameter of 0.72 inches (1.83 centimeters) and an outside diameter of 1.43 inches (3.63 centimeters) with a height of 0.075 inches (0.19 centimeters). Magnetic shield 36 is positioned between secondary charging coil 34 and housing 32 and sized to cover the footprint of secondary charging coil 34.

[0054] Internal telemetry coil 44, having a larger diameter than secondary coil 34, is not completely covered by magnetic shield 36 allowing implantable medical device 16 to communicate with the external programming device with internal telemetry coil 44 in spite of the presence of magnetic shield 36.

[0055] Rechargeable power source 24 can be charged while implantable medical device 16 is in place in a patient through the use of external charging device 48. In a preferred embodiment, external charging device 48 consists of charging unit 50 and external antenna 52. Charging unit 50 contains the electronics necessary to drive primary coil 54 with an oscillating current in order to induce current in secondary coil 34 when primary coil 54 is placed in the proximity of secondary coil 34. Charging unit 50 is operatively coupled to primary coil by cable 56. In an alternative embodiment, charging unit 50 and antenna 52 may be combined into a single unit. Antenna 52 also contains external telemetry coil 46 which may be operatively coupled to charging unit 50 if it is desired to communicate to or from implantable medical device 16 with external charging device 48. Alternatively, antenna 52 may contain external telemetry coil 46 which can be operatively coupled to external programming device 2, either individually or together with external charging unit 48.

[0056] The user interface of external programming unit 2 is illustrated by reference to Figure 3 through Figure 16. The following terms are used throughout the description of the user interface of external programming unit 2.

[0057] As noted below in the explanation of acronyms utilized in the following paragraphs and table, DTC refers to desktop charger which is used to denote the AC power supply (transformer 10) and power cord (cord 8). The DTC is "docked" when external charger 48 is connected to an source of AC power. The DTC is "undocked" when external charger 48 is disconnected from a source of AC power.

DTC	Desktop Charger
ENS	External Neurostimulator
INS	Implanted Neurostimulator
INSR	Another name for the RX1 Patient Recharger. Acronym stands for Implanted Neurostimulator Recharger
LCD	Liquid Crystal Display

[0058] Refer to Figure 3 and Figure 4 for start-up flow and navigation flow, respectively.

[0059] User interface components in the keypad are shown below.

Name	Label	Function
Power button		- Turn display on and off
		- Turn backlight on when held down
Therapy On		- Turn therapy on
		- Turn display on if pressed when programmer is powered down
Therapy Off		- Turn therapy off
		- Turn display on if pressed when programmer is powered down.
Increase		- Change values
Decrease		- Change values
Sync		- Interrogate the implanted device; activate a group
		- Turn display on if pressed when programmer is powered down.
Scroll Up/Down	▲ ▼	- Select displayed items
Scroll Left/Right	◄►	- Access available choices for a selected item

[0060] The LCD is backlit and consists of 96 (Horizontal) x 58 (Vertical) dots with asymmetrical dots 0.35 (H) x 0.4 (V). The active area on the LCD is 33.3 mm (H) x 23.2 mm (V). Four colors of display available. These are named below (from lightest to darkest):

o White

□ Light Gray

□ Dark Gray

□ Black

[0061] Icons are shown in Tables 1-6 below.
Notes:

■ Coordinates specified in the Tables 1-6 below are based on rows numbered 0-57 and columns numbered 0-95

■ Effective display area: rows 1-56, columns 1-94; always leave rows 0 and 57, columns 0 and 95 blank

■ With the exception of status_stim_on, status_stim_offand status_ins_battery_* in Table 1, check_off in Table 2, specified size in Tables 1-6 includes a 1-pixel wide white border around all symbols

Table 1 Icons for Status Line

Name	File	Icon	Size	Coordinates
Status Line Box	Box_17x78		80w x 19h	R0 C2
Stim On	status_stim_on		16w x 15h	R2 C9
Stim Off	status_stim_off		16w x 15h	R2 C9
INS Batt1	status_ins_battery_100		22w x 15h	R2 C29
INS Batt2	status_ins_battery_75		22w x 15h	R2 C29
INS Batt3	status_ins_battery_50		22w x 15h	R2 C29
INS Batt4	status_ins_battery_25		22w x 15h	R2 C29
INS Batt5	status_ins_battery_0		22w x 15h	R2 C29
Programmer Batt1	status_ppg_battery_100		21w x 15h	R2 C55
Programmer Batt2	status_ppg_battery_75		21w x 15h	R2 C55
Programmer Batt3	status_ppg_battery_50		21wx 15h	R2 C55
Programmer Batt4	status_ppg_battery_25		21w x 15h	R2 C55
Programmer Batt5	status_ppg_battery_0		21w x 15h	R2 C55
ENS Batt1	status_ens _battery_100		22w x 15h	R2 C29
ENS Batt2	status_ens_battery_75		22w x 15h	R2 C29
ENS Batt3	status_ens_battery_50		22w x 15h	R2 C29
ENS Batt4	status_ens_battery_25		22w x 15h	R2 C29
ENS Batt5	status_ens_battery_0		22wx. 15h	R2 C29
Small Arrow	small_arrow		10w x 8h	R6 C83

Table 2 Icons for Groups Line

Name	File	Icon	Size	Coordinates
Groups Line Box	box_15x78		80w x 17h	R18 C2
Check Off	check_off		12w x 13h	R20 C9
Check On	check_on		12w x 13h	R20 C9
Scheduled Therapy	scheduled_therapy		18w x 13h	R20 C40
Null Set	null set		12w x 5h	R24 C25
Small Arrow	small_arrow		10w x 8h	R22 C83
Group Labels		--	--	R21 C26

Table 3 Icons for Parameters Line

Name	File	Icon	Size	Coordinates
Parameters Line Box	box_22x78		80wx 24h	R34 C2
Amp1	Amplitude_1		21w x 18h	R38 C7
Amp2	Amplitude_2		21w x 18h	R38 C7
Amp3	Amplitude_3		21w x 18h	R38 C7
Amp4	Amplitude_4		21wx 18h	R38 C7
PW1	Pulsewidth_1		26w x 18h	R37 C7
PW2	Pulsewidth_2		26wx 18h	R37C7
PW3	Pulsewidth_3		26w x 18h	R37 C7
PW4	Pulsewidth_4		26w x 18h	R37 C7
Rate	Rate		23w x 18h	R37 C9
Decimal	decimal	■	6w x 6h	R50a
Comma	Comma		7w x 7h	R49a
Num0	number_0	0	13wx 19h	R37b
Num1	number_1	1	7w x 19h	R37b
Num2	number 2	2	13wx 19h	R37b
Num3	number 3	3	14w x 19h	R37b
Num4	number_4	4	14w x 19h	R37b
Num5	number_5	5	13wx 19h	R37b
Num6	number_6	6	13wx 19h	R37b
Num7	number_7	7	13wx 19h	R37b
Num8	number_8	8	13wx 19h	R37b
Num9	number_9	9	13w x 19h	R37b
Null Value	Null set value	---	40w x 5h	R43 C22
Small Arrow	small_arrow		10w x 8h	R42 C83

Notes a) Column position will vary, depending on parameter value b) All numbers will be displayed in R37; column position will vary, depending on parameter symbol and value

Table 4 Icons for Information Messages and Cautions

Name	File	Icon	Size	Coordinates
Wait Signal	msg_wait_signal		14w x 16h	R3 C5
Communicatin g	msg_communicate		59wx 23h	R26 C18
Communicatin g-ENS	msg_communicate_ens		61wx23 h	R26 C18
All cautions	msg_ppg_information		17wx 17h	R3 C5
INS Battery Low	msg_ins_battery_low		36w x 24h	R27 C30
ENS Battery Low	msg_ens_battery_low		43wx 23h	R28 C26
Programmer Battery Low	msg_ppg_battery_low		36wx 26h	R26 C30
Amp at Upper Limit	msg_upper_limit_amplitude		40w x 17h	R30 C28
PW at Upper Limit	msg_upper_limit_pulsewidth		44wx 14h	R32 C26
Rate at Upper Limit	msg_upper_limit_rate		41wx 18h	R30 C27
Amp at Lower Limit	msg_low_limit_amplitude		41wx 17h	R30 C27
PW at Lower Limit	msg_low_limit_pulsewidth		43w x 14h	R32 C26
Rate at Lower Limit	msg_low-limit-rate		41wx 18h	R30 C27
Poor Communication	msg_poor_communication		59w x 23h	R26 C18
Poor Communicatio n-ENS	msg_poor_communication_e ns		61wx 23h	R26 C18
Sync Up	msg_sync		36w x 29h	R24 C30
Stim On	msg_stim_on		36wx 29h	R24 C30
Codes for Call Your Doctor	Med 15pt font	--	--	R44,C**
IR Communicatio n*	msg_ir_communication		22w x 40h	R14, C37
Connect ENS Cable	msg_cable_problem		78w x 31h	R23 C9

*Note: display msg_wait_signal and msg_ir_communication for IR Communication Screen

Table 5 Icons for Warnings

Name	File	Icon	Size	Coordinates
All warnings	msg_ppg_attention		16w x 14h	R4 C5
Recharge Stimulator	msg_recharge_stim		82w x 24h	R26 C7
Replace ENS Battery	msg_ens_battery_depleted		79w x 27h	R24 C8
Replace Programmer Battery	msg_ppg_battery_depleted		72w x 27h	R14 C12
Sync Up - Required	msg_sync		36w x 29h	R23 C30
Turn Stimulation On	msg_turn_stim_on		36w x 29h	R23 C30
Call Your Doctor	msg_call_your_doctor		57w x 43h	R8 C19
Codes for Call Your Doctor	Med 15pt font	--	--	R44, C**
Sync Up - Start	msg_sync		36wx 29h	R15 C30
Text for Splash*	Med 15pt font	--	--	R14, C23
Wait Signal - Splash*	msg_wait_signal		14w x 16h	R28 C41

*Note: display Text for Splash (Med 15pt font) and Wait Signal - Splash (msg_wait_signal) for Splash Screen **Note: column position will vary, depending on codes displayed

Table 6 Icons for Menu Selections

Name	File	Icon	Size	Coordinates
Box for Menu Selections1	menu_box_26x78		80wx 28h	R0 C2
Box for Contrast,	menu_box_16x78		80wx	R29 C2
Audio and System Info Values			18h
Box for INS/ENS Time Values	menu_box_16x21		23w x 18h	R30 C3
Box for INS/ENS Time-AM/PM	menu_box_16x13		15w x 18h	R30 C47
Box for Time/Number Format and Telemetry N Information Values	menu_box_27x78		80wx 29h	R29 C2
Small arrows	small_arrow		10w x 8h	R2, C83
Audio	menu_audio		15w x 24h	R2 C19
Audio	menu_audio_on		17w x 14h	R31 C19
Audio	menu_audio_off		17w x 14h	R31 C19
Contrast	menu_contrast		26wx 24h	R2 C15
Contrast	menu_slide		72w x 9h	R34 C6
Contrast	menu_slider		6w x 12h	R32 C4
INS/ENS Time	menu clock		24w x 24h	R2 C13
Values for Hours/Minutes	Med 15 pt font	--	--	R35 C3
Colon - INS/ENS Time	menu colon	:	4w x 8h	R36 C24
Time/Number Format	menu_time_number		24w x 24h	R2 C14
Number - OUS Value	number_comma	1.000,00	54wx 13h	R31 C9
Number-US Value	number-decimal	1,000.00	54wx 13h	R31 C9
Time-12h Value	menu_time12h_format	10:00pm	51wx 13h	R43 C9
Time - 24h Value	menu_time24h_format	22:00	36wx 11h	R44 C9
System Info	menu_info6		19wx 19h	R5 C13
System Info Values	Med15pt font7	--	--	--

Notes 1) Displayed on all menu selection screens 2) Row position will vary, depending on menu box that is displayed: R10 for menu_box_26x78; R34 for menu_box_16x78; R35 for menu_box_16x21 and menu_box_16x13; R40 for menu_box_27x78 3) C2 for hours; C27 for minutes , 4) Column position will vary, depending on contrast setting 5) Column position will vary, depending on values 6) Display "PI" next to menu_info for Patient Programmer Information, "NSI" next to menu_info for INS/ENS Information and "TNI" next to menu_info for Telemetry N Information (Refer to Error! Reference source not found., Error! Reference source not found. and Error! Reference source not found.) 7) Med15pt font will be used for Patient Programmer Information and INS/ENS Information.

[0062] Therapy status screen display layout is divided vertically into three lines of information: status line, groups line and parameters line as shown in Figure 5. When a successful initial interrogation has been performed, software will display the Therapy Status Screen of the active set with the following highlighting priority: parameters line if displayed; groups line if displayed; and status line.

[0063] Scroll up and scroll down keys will be used to access the status line, groups line and parameters line on the display. A box highlights user selection. Scroll left and right will be used to cycle through available choices for a selected line. Software will display a "real-time" INS charge level on the status line. The charge level will be updated and displayed whenever a parameter adjustment is made. Software will display programmer battery status on the status line.

[0064] Access to Menu Selections is from the status line are shown in Figure 6. Initial interrogation will include data on all groups currently available to the patient ("Baseline" setting).

[0065] Software will display labels for all groups the user can activate, including those containing no adjustable parameters. Refer to Figure 7 for Group Selections. All unnecessary text will be removed from the display: e.g., if there is only 1 group, software will not display the groups line. Software will not display parameters that the user cannot adjust: i.e., the clinician programmer disallows access or upper and lower limits are the same. The user will access all available groups by scrolling through a linear list: A, B, C, ..., Z. When the user scrolls to a different group, software will display the first adjustable parameter in the group. The user will scroll left/right through available groups to access an inactive group.

[0066] Software will display all adjustable parameters for inactive groups. The user will scroll down to highlight parameters and scroll left or right to view them. If a user presses Therapy Off or Therapy On when the screen displays an inactive group, software will turn the INS off, and display the Therapy Status Screen with the active group highlighted. A check in its check box will be used to indicate an active group (check_on); a check box without a check will be used to indicate inactive groups (check_off). The user will press the Sync key to activate a group at the displayed parameter value(s).

[0067] The neurostimulator does not have to be on to activate a new group. The user can activate a group when therapy is off. The user can activate a new group when the groups line is highlighted or when the parameters line is highlighted. The check box will be updated whenever a new group is activated.

[0068] Software will display labels for all parameters the user can adjust as shown in Figure 8, Parameter Selections. Software will display the first adjustable parameter of the active group when a Sync has been performed for an initial interrogation. The user will access all adjustable parameters by scrolling through a linear list. The order of scrolling through adjustable parameters in a group is Amp1, Amp2, Amp3, Amp4, PW1, PW2, PW3, PW4, Rate, Amp1, ... Refer to Figure 8, Parameter Selections. Increase/decrease keys will be inactive until a session has been initiated - i.e., the INS has been interrogated. When the user presses and holds the increase/decrease keys, software will send a change to the neurostimulator every ½ second. When the user changes a parameter, software will display the updated parameter value.

[0069] Therapy control events are described in screens, information messages and warnings that are displayed on the programmer as shown in Figures 9A, 9B and 9C. Operational requirements are described in tables that specify conditions for entry and expected changes in control.

Power Down Screen (blank display)

Screen Entry: User Control / System Event

- System timeout or Power Button keypress

[0070] 

User Control / System Event	System Response: Table 10 reference
Power button	Start Screen, 14, 15
Therapy On	1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24
Therapy Off	1, 2, 3, 5, 6, 7, 8; 9, 11, 12, 13, 14, 15, 20, 23, 24
Sync	1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24
Scroll up/down/Scroll left/right	Ignore
Increase/Decrease	Ignore
Replace programmer batteries	Splash Screen

Start Screen

Screen Entry: User Control / System Event

- Power button

[0071] 

User Control / System Event	System Response: Table 10 reference
Therapy On	1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24
Therapy Off	1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24
Sync	1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24
Power button/System timeout	Power Down Screen
Scroll up/down/Scroll left/right	Ignore
Increase/Decrease	Ignore
Increase + Decrease and hold for 2-3 seconds	10

Therapy Status Screen

Screen Entry: User Control / System Event

- Telemetry success

[0072] 

User Control / System Event	System Response: Table 10 reference
Therapy On	1, 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24
Therapy Off	1, 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24
Sync	1, 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24
Increase	1, 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 17, 18, 19, 20, 23, 24
Decrease	1, 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 19, 20, 23, 24
Scroll left/right from status line	Audio Screen, Time/Number Formats
Power button/System timeout	Power Down Screen

[0073] The i symbol will be displayed on all information messages as shown in Figure 9B. The user can clear all messages by pressing the 4-way button (Scroll up/down, Scroll left/right), Therapy Off to turn stimulation off or the Power button to turn the display off. If the system times out, the display will turn off (Power Down Screen). Refer to Table 7.

Table 7 Processing Requirements for Information Messages

Message	User Control / System Response: Feedback / Next Screen
INS Battery Low	-	4-way button: Therapy Status
	-	Stim Off: Table 10-1, 2, 3, 6, 11, 12, 13, 14, 15, 23, 24
	-	Stim On: ignore
	-	Sync: ignore
	-	Increase/Decrease: ignore
	-	System timeout or Power button: Power Down
ENS Battery Low	-	4-way button: Therapy Status
	-	Stim Off: Table 10-1, 2, 3, 8, 9, 12, 13, 14, 15, 20, 23, 24
	-	Stim On: ignore
	-	Sync: ignore
	-	Increase/Decrease: ignore
	-	System timeout or Power button: Power Down
Programmer Battery	-	4-way button: Previous screen
Low	-	Stim Off: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 15, 20, 23, 24
	-	Stim On: ignore
	-	Sync: ignore
	-	Increase/Decrease: ignore
	-	System timeout or Power button: Power Down
Amp at Upper Limit	-	4-way button: Therapy Status
	-	Stim Off: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24
	-	Stim On: ignore
'	-	Sync: ignore
	-	Increase/Decrease: ignore
	-	System timeout or Power button: Power Down
PW at Upper Limit	-	4-way button: Therapy Status
	-	Stim Off: Table 10-1,2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23,24
	-	Stim On: ignore
	-	Sync: ignore
	-	Increase/Decrease: ignore
	-	System timeout or Power button: Power Down
Rate at Upper Limit	-	4-way button: Therapy Status
	-	Stim Off: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14,15, 20, 23,24
	-	Stim On: ignore
	-	Sync: ignore
	-	Increase/Decrease: ignore
	-	System timeout or Power button: Power Down
Amp at Lower Limit	-	4-way button: Therapy Status
	-	Stim Off: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23,24
	-	Stim On: ignore
	-	Sync: ignore
	-	Increase/Decrease: ignore
	-	System timeout or Power button: Power Down
PW at Lower Limit	-	4-way button: Therapy Status
	-	Stim Off: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23,24
	-	Stim On: ignore
	-	Sync: ignore
	-	Increase/Decrease: ignore
	-	System timeout or Power button: Power Down
Rate at Lower Limit	-	4-way button: Therapy Status
	-	Stim Off: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14,15, 20, 23, 24
	-	Stim On: ignore
	-	Sync: ignore
	-	Increase/Decrease: ignore
	-	System timeout or Power button: Power Down
Poor Communication -INS	Allow a repeat of the last keypress for Stim On, Sync, Increase and Decrease
	-	4-way button: Sync Up Required
	-	Stim Off: Table 10-1, 2, 3, 5, 6, 11, 12, 13, 14, 15
	-	Stim On: Table 10-1, 2, 3, 5, 6, 11, 12, 13, 14, 15
	-	Sync: Table 10-1, 2, 3, 5, 6, 11, 12, 13, 14, 15
	-	Increase/Decrease: Table 10-1, 2, 3, 5, 6, 11, 12, 13, 14, 15, 16, 17, 18, 19
	-	System timeout or Power button: Power Down
Poor Communication - ENS	Allow a repeat of the last keypress for Stim On, Sync, Increase and Decrease
	-	4-way button: Sync Up Required
	-	Stim Off: Table 10-2, 7, 8, 9, 12, 13, 14, 15, 20, 23, 24
	-	Stim On: Table 10-2, 7, 8, 9, 12, 13, 14, 15, 20, 23, 24
	-	Sync: Table 10-2, 7, 8, 9, 12, 13, 14, 15, 20, 23, 24
	-	Increase/Decrease: Table 10-2, 7, 8, 9, 12, 13, 14, 15, 16, 17, 18, 19, 20, 23, 24
	-	System timeout or Power button: Power Down
Sync Up	-	4-way button: Therapy Status
	-	Stim Off: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24
	-	Stim On: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24
	-	Sync: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13; 14, 15, 20
	-	Increase/Decrease: ignore
	-	System timeout or Power button: Power Down
Turn Stimulation On	-	4-way button: Therapy Status
	-	Stim Off: ignore
	-	Stim On: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24
	-	Sync: ignore
	-	Increase/Decrease: ignore
	-	System timeout or Power button: Power Down
Connect ENS Cable	-	4-way button: Sync Up Required
	-	Stim Off: Table 10-2, 7, 8, 9, 12, 13, 14, 15, 20, 23, 24
		Stim On: Table 10-2, 7, 8, 9, 12, 13, 14, 15, 20, 23, 24
	-	Sync: ignore
	-	Increase/Decrease: ignore
	-	System timeout or Power button: Power Down

[0074] The exclamation mark symbol will be displayed on all warnings as shown in Figure 9C. All warnings will remain on the display until the user takes appropriate action. Refer to Table 8.

Table 8 Processing Requirements for Warning Messages

Message	User Action / System Response: Feedback / Next Screen
Recharge Stimulator	-	System timeout or Power button: Power Down
Replace ENS Battery	-	System timeout or Power button: Power Down
Replace Programmer Battery	-	Replace programmer battery: Start Screen System timeout or Power button: Power Down
Sync Up Required	-	Sync button or Therapy On or Therapy Off: Therapy Status
	-	System timeout or Power button: Power Down
Call Your Doctor	-	Therapy Off and telemetry success with audio feedback: Call Your Doctor
	-	Therapy Off and telemetry failure with audio feedback: Call Your Doctor
	-	System timeout or Power button: Power Down
Call Your Doctor - EOS	-	System timeout or Power button: Power Down
Call Your Doctor - POR	-	System timeout or Power button: Power Down

[0075] "In the box" messages are described in Table 9.

"In the Box" Messages

[0076] 

• Software will notify the user with 3 beeps when "In the Box" messages are displayed
• All "In the Box" messages will remain on the display until the system times out or the user presses the Power button to turn off the display. Refer to Table 9.

Table 9 Processing Requirements for "In the Box" Messages

Message	User Action / System Response: Feedback / Next Screen
INS in the Box	-	System timeout or Power button: Power Down
ENS in the Box	-	System timeout or Power button: Power Down

[0077] Therapy control events are described in Table 10.

Table 10 Processing Requirements for Therapy Control Events and Device Communication

	User Control/System Event	System Response
1.	Communicating with the INS	Display Communicating - INS Message
2.	Successful telemetry	Display Therapy Status Screen
3.	Telemetry failure - INS	Display Poor Communication - INS Message
4.	Software is unable to refresh/update the Therapy Status Screen after a telemetry failure	Display Sync Up Required Warning
5.	INS battery low	Display INS Battery Low Message
6.	INS battery depleted	Display Recharge Stimulator Warning
7.	ENS battery low or battery disconnected	Display ENS Battery Low Message
8.	ENS battery depleted	Display Replace ENS Battery Warning
9.	ENS screening cable disconnected	Display Connect ENS Cable Message
10.	User presses Increase + Decrease and holds for 2-3 seconds	Display Patient Information Screen (Error! Reference source not found.)
11.	INS error-EOS	Display Call Your Doctor - EOS Warning
12.	INS error - battery voltage too high; /ENS error - POR, battery voltage too high	Display Call Your Doctor Warning
13.	System Error and Warning	Display Call Your Doctor Warning
14.	Patient programmer battery low	Display Programmer Battery Low Message
15.	Patient programmer battery depleted	Display Replace Programmer Battery Warning
16.	Parameter at lower limit	Display At Lower Limit Message
17.	Parameter at upper limit or out of reg	Display At Upper Limit Message
18.	Increase with therapy off	Display Turn Stimulation On Message
19.	Increase/decrease parameter of inactive group	Display Sync Up Message
20.	ENS error - POR, battery voltage too low	Display Communicating - ENS, followed by INS/ENS Time with 12:00 displayed
21.	Communicating via IR	Display IR Communication Screen
22.	Replace programmer batteries	Display Splash Screen
23.	Communicating with the ENS	Display Communicating - ENS Message
24.	Telemetry failure - ENS	Display Poor Communication - ENS Message
25.	INS error - locked normal	Display INS in the Box Message
26.	ENS error - ENS has no programs or groups	Display ENS in the Box Message
27.	INS error - POR	Display Call Your Doctor - POR Warning

[0078] Access to menu selections is from the status line on the Therapy Screen as shown in Figure 10.

[0079] The display is divided vertically into two lines of information: menu option line and value line. Scroll up and down keys will be used to access the menu option line and the value line on the display. A box highlights user selection. Scroll right and left and increase/decrease keys will be used to change values for Audio, Contrast, Time/Number Format and the Information options. In addition, Increase/decrease keys will be used to change values.

[0080] Software will display screens for the menu options in Table 11 Menu Selections.

Table 111 Menu Selections and Navigation Flow

Menu Item	References
Audio	Figure 11, Table 12-1, 3, 9
Contrast	Figure 12, Table 12-1, 3, 4, 6, 7, 9
INS/ENS Time	Figure 13, Table 12-1, 2,4,7, 8, 9
Time/Number Format	Figure 14, Table 12-1, 3, 9 1
Patient Programmer Information	Figure 15, Table 12-1, 2, 9, 10
INS/ENS Information	Figure 16, Table 12-1, 2, 9, 10
Telemetry N Information	Figure 16A, Table 12-1, 2, 9, 10

[0081] The user interface of the external charger is described below. A description of the user interface for an external recharger for an implantable medical device is described. The appearance of the screens and how users interact with these screens are defined.

[0082] The following terms are used throughout the description of the user interface for the external charger.

DTC	Desktop Charger
ENS	External Neurostimulator
INS	Implanted Neurostimulator
INSR	Another name for the RX1 Patient Recharger. Acronym stands for Implanted Neurostimulator Recharger
LCD	Liquid Crystal Display

[0083] Refer to Figure 17 and Figure 18 for navigation flow.

[0084] Figure 17 illustrates a process for charging rechargeable power source 24 in implantable medical device 16 by using external charging device 48.

[0085] In order to charge rechargeable power source 24; a patient may use belt 12 to attach external antenna 52 to the patient's body at approximately the location of implanted medical device 16. It is desirable that primary coil 54 of external antenna 52 be aligned as closely as possible with secondary coil 34 of implantable medical device 16. Techniques for attaching external antenna 52 to the patient's body and positioning primary coil 54 in close proximity to secondary coil 34 can be found in co-pending United States Patent Application Serial No. 10/837,506, filed April 30, 2004.

[0086] After affixing external antenna 52 to the approximate location of implantable medical device 16, the patient (or other user such as a medical professional or family member assisting the patient) may then press (step 110) the "Start Charge" button 90 (Figure 1) on charging unit 50.

[0087] Charging unit 50 then determines (step 112) if telemetry with implantable medical device 16 is successful. If telemetry is unsuccessful (step 114), an error message is generated such as a telemetry timeout (Reposition Antenna - Press Start Charge), system error (Antenna Too Hot) or external charging device 48 error due to INSR battery low or INSR battery depleted and external charging device displays the appropriate message. If telemetry is successful, then charging unit 50 waits (step 116) and the appropriate charge status may be indicated (step 118) in the display of charging unit 50.

[0088] If charging of rechargeable power source 24 is not yet complete (step 120), charging unit 50 returns through step 118. The surface temperature of antenna 52 is monitored as well as the charging current and battery voltage levels. An error message is generated and charging is suspended if measurements are not within limits.

[0089] Once charging of rechargeable power 24 is complete (step 122), charging unit 50 indicates in the display that charging is complete and the user may press the "Stop Charge" button 92 on charging unit 50 to terminate the charging process. Of course, it is recognized and understood that the "Stop Charge" button 92 may be pressed at any time during the charging process in order to terminate the charging process, i.e., the user need not wait until the complete charging has been indicated.

[0090] Charging unit 50 may be operated to charge rechargeable power 24 in implantable medical device 16 by the use of only two buttons, namely the "Start Charge" button 90 and the "Stop Charge" button 92. These are the only two buttons which need be used. While a preferred embodiment of charging unit 50 does contain a third button, namely "Silence" button 94, this third button is not necessary. "Silence" button 94 is used only to disable, or to re-enable, audio output of charging unit 50. Since audio feedback is not required for the charging process, this button may be used or not at the convenience of the user.

[0091] In an alternative embodiment, charging unit 50 may itself be powered by a rechargeable power source, such as a battery. Since the charging process could take several hours, it would be desirable.

[0092] Figure 18 illustrates the process used to charge the external charging unit 48. The external charging unit 48 is connected (step 124) to a suitable power source, such as a readily available AC power outlet. A check is made (step 126) to determine whether a "recharge event", i.e., an alert or alarm condition, has occurred and, if so, issue the appropriate message (step 128). If a "recharge event" has not occurred, the process updates and displays (step 130) the charge status of external charging device 48. If recharge of external charging is not complete (step 132), the process again updates and displays the charging status in step 130. Once charging of external charging device 48 is complete (step 134), charging unit 50 displays a message indicative of a complete charging process.

[0093] The LCD is backlit and consists of 96 (Horizontal) x 58 (Vertical) dots with asymmetrical dots 0.35 (H) x 0.4 (V). The active area on the LCD is 23.2 mm (V) x 33.3 mm (H).

[0094] Four colors of display are available. These are named below (from lightest to darkest):

□ White

□ Light Gray

□ Dark Gray

□ Black

[0095] The keypad has the following buttons.

Name	Label	Function
Start Charge		-	Start charge
		-	Turn display on if pressed when recharger is powered down
Stop Charge		-	Stop charge
Audio		-	Toggle audio on/off
		-	Turn display on if pressed when recharger is powered down
Therapy On		-	Turn therapy on
		-	Turn display on if pressed when recharger is powered down
Therapy Off		-	Turn therapy off
		-	Turn display on if pressed when recharger is powered down

[0096] See Tables 11 through 16 below for icons.

Table 12 Icons for Status Line

Name	File	Icon	Size	Coordinates
INSR Wait Signal	msg_insr_wait_signal		14w x 16h	R3 C5
Therapy On	status_stim_on		16w x 16h	R1 C6
Therapy Off	status_stim_off		16w x 16h	R1 C6
Audio On	status_beep_on		17w x 14h	R3 C27
Audio Off	status_beep_off		17w x 14h	R3 C27
INSR Batt1	status_hhp_battery_100		21w x 15h	R2 C49
INSR Batt2	status_hhp_battery_75		21w x 15h	R2 C49
INSR Batt3	status_hhp_battery_50		2.1w x 15h	R2 C49
INSR Batt4	status_hhp_battery 25		21w x 15h	R2 C49
INSR Batt5	status_hhp_battery_0		21w x 15h	R2 C49
Power Source Symbol	status_plug		16w x 11h	R6 C75

Table 13 Icons for INS Recharge Progress Line

Name	File	Icon	Size	Coordinates
Wait Signal	Wait_signal		75wx 22h	R20 C10
Recharging Antenna	recharge_antenna		31w x 20h	R21 C7
Recharging Sprites	energy_symbol		11w x 11h	R25 C40
INS Charging 0 to 25%	ms_charge_0_to_25		36w x 24h	R20 C53
INS Charging 25 to 50%	ins_charge 25_to 50		36wx 24h	R20 C53
INS Charging 50 to 75%	ins_charge_50_to_75		36wx 24h	R20 C53
INS Charging 75 to 100%	ins_charge_75_to_100		36w x 24h	R20 C53
INS Charging 0%	ins_charge_0		36w x 24h	R20 C53
INS Charging 25%	ins_charge_25		36w x 24h	R20 C53
INS Charging 50%	ins_charge_50		36w x 24h	R20 C53
INS Charging 75%	ins_charge_75		36w x 24h	R20 C53
INS Charging 100%	ms_charge_100		36wx 24h	R20 C53
INS Recharge Complete	Msg_ins_charge_complete		36w x 34h	R20 C30
Antenna Too Hot	Msg_antenna_too_hot		56w x 36h	R20 C20

Table 14 Icons for INS Recharge Efficiency Line

Name	File	Icon	Size	Coordinates
Recharge Efficiency-0	recharge_effciency_0		65wx 9h	R46 C15
Recharge Efficiency-1	recharge_efficiency_1		65w x 9h	R46 C15
Recharge Efficiency-2	recharge_efficiency_2		65wx 9h	R46 C15
Recharge Efficiency-3	recharge_efficiency_3		65w x 9h	R46 C15
Recharge Efficiency-4	recharge_efficiency_4		65w x 9h	R46 C 15
Recharge Efficiency-5	recharge_efficiency_5		65w x 9h	R46 C15
Recharge Efficiency-6	recharge_efficiency_6		65w x 9h	R46 C15
Recharge Efficiency-7	recharge_efficiency_7		65w x 9h	R46 C15
Recharge Efficiency-8	recharge_efficiency_8		65w x 9h	R46 C15

Table 15 Icons for INSR Charge Status Screen

Name	File	Icon	Size	Coordinates
Therapy On	status_stim_on		16w x 16h	R1 C6
Therapy Off	status_stim_off		16w x 16h	R1 C6
Audio On	status_beep_on		17w x 14h	R3 C27
Audio Off	status_beep_off		17w x 14h	R3 C27
INSR Charging 0 to 25%	Insr_charge_0_to_25		36w x 26h	R24 C10
INSR Charging 25 to 50%	Insr_charge_25_to_50		36wx 26h	R24 C10
INSR Charging 50 to 75%	Insr_charge_50_to_75		36wx 26h	R24 C10
INSR Charging 75 to 100%	Insr_charge_75_to_100		36w x 26h	R24 C10
INSR Charging 0%	Insr_charge_0		36w x 26h	R24 C10
INSR Charging 25%	Insr_charge_25		36w x 26h	R24 C10
INSR Charging 50%	Insr_charge_50		36wx 26h	R24 C10
INSR Charging 75%	Insr_charge_75		36w x 26h	R24 C10
INSR Charging 100%	Insr_charge_100		26h 36wx 26h	R24 C10
Recharging Sprites	energy_symbol		11w x 11h	R37 C48
INSR Plug	Insr_plug		29w x 23h	R26 C57

Table 16 Icons for Information_Messages

Name	File	Icon	Size	Coordinate s
All information messages	msg_insr_information		17w x 17h	R3 C5
Antenna Too Hot	msg_antenna_too_hot		56w x 36h	R20 C20
INS Battery Low	msg_ins_battery_low		36w x 24h	R27 C30
INS Recharge Interrupted	msg_jns_charge_interrupte d	Note 1	36w x 24h	R27 C30
INS Recharge Complete	msg_ins_charge_complete		36w x 34h	R18 C30
INSR Battery Low	msg_insr_battery_low		3bw x 26h	R26 C30
INSR Recharge Interrupted	insg_insr_charge_interrupt ed	Note 2	36w x 26h	R26 C30
INSR Recharge Complete	msg_insr_charge_complete		36w x 34h	R18 C30
Call Your Doctor - ERI	msg_call_your_doctor		57w x 43h	R8 C19
IR Communication	msg_ir_communication: Note 3		22w x 43h	R11 C37
Text for Splash	Med 15pt font Note 4	--	--	R14, C23
Wait Signal - Splash	msg_wait_signal Note 4		14w x 16h	R28 C41
Connect INSR Antenna	msg_connect_insr_antenna		68w x 26h	R25 C14

Note 1:display INS battery status symbol for current charge level: ins_charge_25, ins_charge_50, ins_charge_75 (refer to Table 12), or msg_ins_charge_complete (refer to Table 15) Note 2:display INSR battery status symbol for current charge level: insr_charge_25, insr_charge_50, insr_charge_75 (refer to Table 14) Note 3: display msg_insr_wait_signal (refer to Table 11) and msg_ir_communication (refer to Table 5) for IR Communication Screen Note 4: display Text for Splash (Med 15pt font) and Wait Signal - Splash (msg_wait_signal) for Splash Screen

Table 17 Icons for Warning Messages and Physician Recharge Mode

Name	File (*.bmp)	Icon	Size	Coordinate s
All warning messages	msg_insr_attention		16w x 14h	R4 C5
Reposition Antenna	msg_reposition_antenna		47w x 27h	R25 C6
Reposition Antenna -Stim	msg_reposition_antenna_st im		47w x 27h	R25 C6
Press Start Charge	msg_press_test		36wx 29h	R23 C54
Press Therapy Off	msg_press_stim_off		36wx 29h	R23 C54
Press Therapy On	msg_press_stim_on		36wx 29h	R23 C54
Recharge Stimulator	msg_recharge_stim		82wx 24h	R26 C7
Recharge INSR	msg_recharge_insr	26h	76w x 26h	R25 C10
Call Your Doctor	msg_call_your_doctor		57w x 43h	R8 C19
Physician Recharge1	msg_phys_recharge	26h	61wx 26h	R7 C17
Physician Recharge - Antenna Too Hot2	msg_antenna_too_hot		56w x 36h	R2 C20
Values for Minutes/Seconds	Med18pt font	--	--	R40 C3
System Info	system_info4		19w x 19h	R3 C5
System Info Values	system font5	--	--	--

[0097] The INS charge status screen display is divided vertically into three lines of information: status line, recharge progress line and recharge efficiency line. Refer to Figure 19 and Figure 20.

[0098] Therapy On, Therapy Off, Start Charge and Stop Charge are dedicated function keys. When the display is blank and the user presses Therapy On, Therapy Off or Start Charge, software will perform the function and turn the display on. System timeout is < 30 seconds.

[0099] The INS battery status display has 5 settings: 0%, 25%, 50%, 75% and 100%. During recharge, software will display the appropriate quartiles in solid fill and the next higher quartile in a flashing on/off manner every second. The exception is 100%. Even if the INS battery voltage indicates 100%, software will flash the last quartile until the recharge session is complete.

[0100] The INSR charge status screen display is divided vertically into two lines of information: status line and recharge progress line. Refer to Figure 21, INSR Charge Status Screen, and Figure 22, Recharging the INSR.

[0101] The INSR battery status has 5 settings: 0%, 25%, 50%, 75% and 100%. During recharge, software will display the appropriate quartiles in solid fill and the next higher quartile in a flashing on/off manner every second. The exception is 100%. Even if the INSR battery voltage indicates 100%, software will flash the last quartile until the recharge session is complete.

[0102] Recharging events are described in screens, information messages and warnings that are displayed on the recharger as shown in Figure 23A and Figure 23B. Operational requirements are described in tables that specify conditions for entry and expected changes in control. Refer to the operational requirements for each screen in this section.

[0103] The i symbol will be displayed on all information messages. With the exception of INSR System Information screen, the user can exit the messages by pressing Audio or wait for the system to timeout. Therapy On and Off will always be active when the messages are displayed. When the user presses Therapy On or Off, software will turn stimulation on/off and clear the information message.

[0104] The exclamation mark symbol will be displayed on all warnings. All warnings will remain on the display until the user takes appropriate action.

1- Power Down Screen (blank display)

Screen Entry: User Control / System Event

- System timeout from Start Screen - Not Docked

[0105] 

User Control / System Event	System Response: Feedback / Next Screen (requirement)
Therapy On/Off	-	Telemetry success: Start Screen - Not Docked with Therapy On/Off icon on status line (Table 17-22)
	-	Telemetry event: refer to Table 18
Start Charge	-	Antenna temperature OK: Wait Screen (Table 17-1)
	-	Antenna too hot: Antenna Too Hot Message (Table 17-30)
	-	Antenna failure: Call Your Doctor Warning (Table 17-18)
	-	Antenna disconnected: Connect INSR Antenna Message (Table 17-14)
	-	INSR battery low: INSR Battery Low Message (Table 17-8)
	-	INSR battery depleted: Recharge INSR Warning (Table 17-9)
Stop Charge	-	No change
Audio	-	Start Screen - Not Docked (Table 17-24, 25)
	-	INSR battery low: INSR Battery Low Message (Table 17-8)
	-	INSR battery depleted: Recharge INSR Warning (Table 17-9)
Attach DTC	-	INSR recharge complete: INSR Recharge Complete Message (Table 17-11)
	-	INSR recharge incomplete: INSR Charge Status Screen (Table 17-7)
Audio + Stop Charge	-	INSR System Information Message (Table 17-17)
Audio + Start Charge and hold for > 10 seconds	-	Antenna temperature OK: Physician Recharge Screen (Table 17-21)
	-	Antenna too hot: Physician Recharge - Antenna Too Hot (Table 17-31)

2- Start Screen - Not Docked

Screen Entry: User Control / System Event

[0106] 

• Therapy On/Off keys when the recharger is powered down
• Audio key when the recharger is powered down
• Any key from Splash Screen
• Detach DTC
• System timeout or message clear when DTC is detached
• Stop Charge from Physician Recharge Screen or Physician Recharge - Antenna Too Hot Screen
• Host terminates the session, the Reset button is activated or the user presses Audio from IR Communication Screen

User Control / System Event	System Response: Feedback / Next Screen (requirement)
Therapy On/Off	-	Telemetry success: Therapy On/Off icon on status line (Table 17-22)
	-	Telemetry event: refer to Table 18
Start Charge	-	Antenna temperature OK: Wait Screen (Table 17-1)
	-	Antenna too hot: Antenna Too Hot Message (Table 17-30)
	-	Antenna failure: Call Your Doctor Warning (Table 17-18)
	-	Antenna disconnected: Connect INSR Antenna Message (Table 17-14)
	-	INSR battery low: INSR Battery Low Message (Table 17-8)
	-	INSR battery depleted: Recharge INSR Warning (Table 17-9)
Stop Charge	-	No change
Audio	-	Audio icon (Table 17-24)
INSR battery low	-	INSR Battery Low Message (Table 17-8)
INSR battery depleted	-	Recharge INSR Warning (Table 17-9)
System error	-	Call Your Doctor Warning (Table 17-18)
Attach DTC	-	INSR recharge complete: INSR Recharge Complete Message (Table 17-11)
	-	INSR recharge incomplete: INSR Charge Status Screen (Table 17-7)
Audio + Stop Charge	-	INSR System Information Message (Table 17-17)
Audio + Start Charge and hold for > 10 seconds	-	Antenna temperature OK: Physician Recharge Screen (Table 17-21)
	-	Antenna too hot: Physician Recharge - Antenna Too Hot (Table 17-31)
System timeout	-	Power Down Screen

3- Start Screen - Docked

Screen Entry: User Control / System Event

[0107] 
- System timeout or message clear
- Any key from Splash Screen
- Host terminates the session, the Reset button is activated or the user presses Audio from the Splash Screen
- Stop Charge from Physician Recharge Screen or Physician Recharge - Antenna Too Hot Screen

User Control / System Event	System Response: Feedback / Next Screen (requirement)
Therapy On/Off	-	Telemetry success: Therapy On/Off icon on status line (Table 17-22)
	-	Telemetry event: refer to Table 18
Start Charge	-	Antenna temperature OK: Wait Screen (Table 17-1)
	-	Antenna too hot: Antenna Too Hot Message (Table 17-30)
	-	Antenna failure: Call Your Doctor Warning (Table 17-18)
	-	Antenna disconnected: Connect INSR Antenna (Table 17-14)
Stop Charge	-	No change
Audio	-	Audio icon (Table 17-24)
System error	-	Call Your Doctor Warning (Table 17-18)
Detach DTC	-	Start Screen-Not Docked
Audio + Stop Charge	-	INSR System Information Message (Table 17-17)
Audio + Start Charge and hold for > 10 seconds	-	Antenna temperature OK: Physician Recharge Screen (Table 17-21)
	-	Antenna too hot: Physician Recharge - Antenna Too Hot (Table 17-31)

4- Wait Screen

Screen Entry: User Control / System Event

[0108] 
- Start Charge
- Antenna temperature OK
- System timeout or message clear

User Control / System Event	System Response: Feedback / Next Screen (requirement)
Therapy On/Off	-	No change
Telemetry success	-	INS Charge Status Screen or INS Charge Status - 90 to 100% Screen (Table 17-2)
Telemetry failure or poor charging condition	-	Reposition Antenna - Press Start Charge Warning (Table 17-12)
INS error: ERI	-	Call Your Doctor - ERI Message (Table 17-19)
INS error: POR	-	Call Your Doctor - POR Message (Table 17-27)
INS error: EOS, battery voltage too high	-	Call Your Doctor Warning (Table 17-18)
INSR battery low	-	INSR Battery Low Message (Table 17-8)
INSR battery depleted	-	Recharge INSR Warning (Table 17-9)
Antenna too hot	-	INS Charge Status - Antenna Too Hot (Table 17-13)
Antenna failure	-	Call Your Doctor Warning (Table 17-18)
Antenna disconnected	-	Connect INSR Antenna Message (Table 17-14)
System error	-	Call Your Doctor Warning (Table 17-18)
Start Charge	-	No change
Stop Charge (not docked)	-	Start Screen - Not Docked
Stop Charge (docked)	-	INSR recharge incomplete: INSR Charge Status Screen (Table 17-7)
	-	INSR recharge complete: INSR Recharge Complete Message (Table 17-11)
Audio	-	No change
Attach DTC	-	No change
Detach DTC	-	No change
Audio + Stop Charge	-	No change
Audio + Start Charge and hold for > 10 seconds	-	No change

5- INS Charge Status Screen

Screen Entry: User Control / System Event

[0109] 

• Telemetry success
• System timeout or message clear
• Antenna temperature OK

User Control / System Event	System Response: Feedback / Next Screen (requirement)
Therapy On/Off	-	Telemetry success: Therapy On/Off icon on status line (Table 17-22)
	-	Telemetry event: refer to Table 18
Start Charge	-	Antenna temperature OK: refresh recharge efficiency line (Table 17-26)
	-	Antenna too hot: INS Charge Status - Antenna Too Hot (Table 17-13)
Stop Charge	-	Charge complete: INS Recharge Complete Message (Table 17-6)
	-	Charge incomplete and not INS battery low: INS Recharge Interrupted Message (Table 17-5)
	-	INS battery low: INS Battery Low Message (Table 17-3)
	-	INS battery depleted: Recharge Stimulator Warning (Table 17-4)
Audio	-	Toggle Audio icon (Table 17-24)
Attach DTC	-	Power source symbol on status line (Table 17-23)
Detach DTC	-	INSR battery low: INSR Battery Low Message (Table 17-8)
	-	INSR battery depleted: Recharge INSR Warning (Table 17-9)
	-	Status line without power source symbol (Table 17-23)
INS recharge complete	-	INS Recharge Complete Message (Table 17-6)
INS error: ERI	-	Call Your Doctor ERI Message (Table 17-19)
INS error: POR	-	Call Your Doctor - POR Message (Table 17-27)
INS error: EOS, battery voltage too high	-	Call Your Doctor Warning (Table 17-18)
Antenna too hot	-	INS Charge Status - Antenna Too Hot (Table 17-13)
Antenna failure	-	Call Your Doctor Warning (Table 17-18)
Antenna disconnected	-	Connect INSR Antenna Message (Table 17-14)
INSR battery low	-	INSR Battery Low Message (Table 17-8)
INSR battery depleted	-	Recharge INSR Warning (Table 17-9)
INSR recharge complete	-	INSR Batt1 on status line (Table 17-25)
System error	-	Call Your Doctor Warning (Table 17-18)
Audio + Stop Charge	-	No change
Audio + Start Charge and hold for > 10 seconds	-	No change

6- INSR Charge Status Screen

Screen Entry: User Control / System Event

[0110] 

• Attach DTC from Power Down Screen, Start Screen - Not Docked or Recharge INSR Warning
• Attach DTC from INSR Battery Low Message when not charging INS - System timeout or message clear

User Control / System Event	System Response: Feedback / Next Screen (requirement)
Therapy On/Off	-	Telemetry success: Therapy On/Off icon on status line (Table 17-22)
	-	Telemetry event: refer to Table 18
Start Charge	-	Antenna temperature OK: Wait Screen (Table 17-1)
	-	Antenna too hot: Antenna Too Hot Message (Table 17-30)
Audio	-	Toggle Audio icon (Table 17-24)
Detach DTC	-	Charge incomplete and not INSR battery low: INSR Recharge Interrupted Message (Table 17-10)
	-	INSR battery low: INSR Battery Low Message (Table 17-8)
	-	INSR battery depleted: Recharge INSR Warning (Table 17-9)
	-	INSR recharge complete: INSR Recharge Complete Message (Table 17-11)
INSR recharge complete	-	INSR Recharge Complete Message (Table 17-11)
Audio + Start Charge and hold for > 10 seconds	-	Antenna temperature OK: Physician Recharge Screen (Table 17-21)
	-	Antenna too hot: Physician Recharge - Antenna Too Hot (Table 17-31)
System error	-	Call Your Doctor Warning (Table 17-18) ,

7- Physician Recharge Screen

Screen Entry: User Control / System Event

[0111] 

• Audio + Start Charge and hold for > 10 seconds
• Antenna temperature OK
• System timeout or message clear

User Control / System Event*	System Response: Feedback / Next Screen (requirement)
Successful communication with INS	-	INS Charge Status Screen (Table 17-2)
Timer goes to zero and system times out (not docked)	-	Start Screen - Not Docked without Therapy On/Off icon on status line (Table 17-22)
Timer goes to zero and system times out (docked)	-	INSR recharge incomplete: INSR Charge Status Screen (Table 17-7) INSR recharge complete: INSR Recharge Complete Message (Table 17-11)
Stop Charge (not docked)	-	Start Screen - Not Docked
Stop Charge (docked)	-	Start Screen - Docked
Detach DTC	-	INSR battery low: INSR Battery Low Message (Table 17-8)
	-	INSR battery depleted: Recharge INSR Warning (Table 17-9)
Antenna too hot	-	Physician Recharge - Antenna Too Hot (Table 17-31)
Antenna failure	-	Call Your Doctor Warning (Table 17-18)
Antenna disconnected	-	Connect INSR Antenna Message (Table 17-14)
System error	-	Call Your Doctor Warning (Table 17-18)
INSR battery low	-	INSR Battery Low Message (Table 17-8)
INSR battery depleted	-	Recharge INSR Warning (Table 17-9)
INSR recharge complete	-	No change

*Note: all keys inactive except Stop Charge 8-IR Communication Screen

Screen Entry: User Control / System Event

[0112] 

• Reset button from any screen when DTC is not docked and IR command is received

Processing Requirements

[0113] 

• All keys inactive
• Software will display the screen until the host terminates the session, the Reset button is activated or the Audio key is pressed. (Table 17-28)
• When the host terminates the session or the Reset button is activated, software will display Start Screen - Not Docked.

9- INS Battery Low Message

Screen Entry: User Control / System Event

[0114] 

• Therapy On/Off

Entry Screen		User Control / System Event: Next Screen
-	Power Down	-	Audio key or system timeout: Start Screen - Not Docked with Therapy On/Off icon on status line (Table 17-22)
-	Start Screen - Not Docked
		-	Therapy On/Off and telemetry success: Start Screen - Not Docked with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry event: Refer to Table 18
		-	Start Charge and antenna temperature OK: Wait Screen (Table 17-1)
		-	Start Charge and antenna too hot: Antenna Too Hot Message (Table 17-30)
		-	Stop Charge: no change
		-	Attach DTC: no change
Start Screen - Docked		-	Audio key or system timeout: Start Screen - Docked with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry success: Start Screen - Docked with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry event: Refer to Table 18
		-	Start Charge and antenna temperature OK: Wait Screen (Table 17-1)
		-	Start Charge and antenna too hot: Antenna Too Hot Message (Table 17-30)
		-	Stop Charge: no change
		-	Detach DTC: no change
INSR Charge Status		-	Audio key or system timeout: INSR Charge Status Screen with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry success: INSR Charge Status with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry event: Refer to Table 18
		-	Start Charge and antenna temperature OK: Wait Screen/INS Charge Status (Table 17-1)
		-	Start Charge and antenna too hot: Antenna Too Hot Message (Table 17-30)
		-	Stop Charge: no change
		-	Detach DTC: no change

INS Battery Low Message - continued

Screen Entry: User Control / System Event

[0115] 

• Stop Charge

Entry Screen		User Control / System Event: Next Screen
-	INS Charge Status (not docked)	-	Audio key or system timeout: Start Screen - Not Docked
		-	Therapy On/Off and telemetry success: Start Screen - Not Docked with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry event: Refer to Table 18
		-	Start Charge and antenna temperature OK: Wait Screen (Table 17-1)
		-	Start Charge and antenna too hot: Antenna Too Hot Message (Table 17-30)
		-	Stop Charge: no change
		-	Attach DTC: no change
-	INS Charge Status (docked)	-	Audio key and INSR recharge incomplete: INSR Charge Status with Therapy On/Off icon on status line (Table 17-22)
		-	Audio key and INSR recharge complete: INSR Recharge Complete Message (Table 17-11)
		-	Therapy On/Off and telemetry success and INSR recharge incomplete: INSR Charge Status with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry success and INSR recharge complete: Start Screen - Docked with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry event: Refer to Table 18
		-	Start Charge and antenna temperature OK: Wait Screen (Table 17-1)
		-	Start Charge and antenna too hot: Antenna Too Hot Message (Table 17-30)
		-	Stop Charge: no change
		-	Detach DTC: no change

10- INS Recharge Interrupted Message

Screen Entry: User Control / System Event

[0116] 

• Stop Charge

Entry Screen		User Control / System Event: Next Screen
-	INS Charge Status (not docked)	-	Audio key or system timeout: Start Screen - Not Docked
		-	Therapy On/Off and telemetry success: Start Screen - Not Docked with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry event: Refer to Table 18
		-	Start Charge and antenna temperature OK: Wait Screen (Table 17-1)
		-	Start Charge and antenna too hot: Antenna Too Hot Message (Table 17-30)
		-	Stop Charge: no change
		-	Attach DTC: no change
-	INS Charge Status (docked)	-	Audio key or system timeout and INSR recharge incomplete: INSR Charge Status with Therapy On/Off icon on status line (Table 17-22)
		-	Audio key or system timeout and INSR recharge complete: INSR Recharge Complete Message (Table 17-11)
		-	Therapy On/Off and telemetry success and INSR recharge incomplete: INSR Charge Status with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry success and INSR recharge complete: Start Screen - Docked with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry event: Refer to Table 18
		-	Start Charge and antenna temperature OK: Wait Screen (Table 17-1)
		-	Start Charge and antenna too hot: Antenna Too Hot Message (Table 17-30)
		-	Stop Charge: no change
		-	Detach DTC: no change

11- INS Recharge Complete Message

Screen Entry: User Control / System Event

[0117] 

• Stop Charge
• INS recharge complete

Entry Screen		User Control / System Event: Next Screen
-	INS Charge Status (not docked)	-	Audio key or system timeout: Start Screen-Not Docked
		-	Therapy On/Off and telemetry success: Start Screen - Not
-	INS Charge Status - 90 to 100% (not docked)		Docked with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry event: Refer to Table 18
		-	Start Charge and antenna temperature OK: Wait Screen (Table 17-1)
		-	Start Charge and antenna too hot: Antenna Too Hot Message (Table 17-30)
		-	Stop Charge: no change
		-	Attach DTC: no change
-	INS Charge Status (docked)	-	Audio key or system timeout and INSR recharge incomplete: INSR Charge Status
-	INS Charge Status- 90 to 100% (docked)	-	Audio key or system timeout and INSR recharge complete: INSR Recharge Complete Message (Table 17-11)
		-	Therapy On/Off and telemetry success and INSR recharge incomplete: INSR Charge Status with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry success and INSR recharge complete: Start Screen - Docked with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry event: Refer to Table 18 Start Charge and antenna temperature OK: Wait Screen (Table 17-1)
		-	Start Charge and antenna too hot: Antenna Too Hot Message (Table 17-30)
		-	Stop Charge: no change Detach DTC: no change

12- INSR Battery Low Message

Screen Entry: User Control / System Event

[0118] 

• Therapy- On/Off

Entry Screen		User Control / System Event: Next Screen
-	Power Down	-	Audio key or system timeout: Start Screen - Not Docked with Therapy On/Off icon on status line (Table 17-22)
-	Start Screen - Not Docked
		-	Therapy On/Off and telemetry success: Start Screen - Not Docked with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry event: Refer to Table 18
		-	Start Charge and antenna temperature OK: Wait Screen (Table 17-1)
		-	Start Charge and antenna too hot: Antenna Too Hot Message (Table 17-30)
		-	Stop Charge: no change
		-	Attach DTC: INSR Charge Status with Therapy On/Off icon on status line (Table 17-23)
-	INS Charge Status	-	Audio key or system timeout: previous screen with Therapy
-	INS Charge Status - 90 to 100%		On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry success: Wait Screen
		-	Therapy On/Off and telemetry event: Refer to Table 18
		-	Start Charge and antenna temperature OK: Wait Screen (Table 17-1)
		-	Start Charge and antenna too hot: INS Charge Status - Antenna Too Hot Screen (Table 17-13)
		-	Stop Charge: Start Screen - Not Docked
		-	Attach DTC: previous screen with Therapy On/Off icon and Power Source Symbol on status line (Table 17-22, 23)

Screen Entry: User Control / System Event

[0119] 

• Start Charge

Entry Screen		User Control / System Event: Next Screen
-	Power Down	-	Audio key or system timeout: Wait Screen/INS Charge Status/
-	Start Screen - Not Docked		INS Charge Status - 90 to 100%
		-	Therapy On/Off and telemetry success: Wait Screen/INS Charge/ INS Charge Status - 90 to 100% Status with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry event: Refer to Table 18
		-	Start Charge and antenna temperature OK: Wait Screen (Table 17-1)
		-	Start Charge and antenna too hot: Antenna Too Hot Message (Table 17-30)
		-	Stop Charge: no change
		-	Attach DTC: Wait Screen/INS Charge Status/ INS Charge Status - 90 to 100%

INSR Battery Low Message - continued

Screen Entry: User Control / System Event

[0120] 

• Audio

Entry Screen	User Control / System Event: Next Screen
Power Down	-	Audio key or system timeout: Start Screen - Not Docked
	-	Therapy On/Off and telemetry success: Start Screen - Not Docked with Therapy On/Off icon on status line (Table 17-22)
	-	Therapy On/Off and telemetry event: Refer to Table 18
	-	Attach DTC: INSR Charge Status

Screen Entry: User Control / System Event

[0121] 

• INSR battery low condition

Entry Screen	User Control / System Event: Next Screen
Wait Screen	Audio key or system timeout or Attach DTC: Wait Screen/INS Charge Status/ INS Charge Status - 90 to 100%
Physician Recharge	Audio key or system timeout or Attach DTC: Physician Recharge
Physician Recharge - Antenna Too Hot	Audio key or system timeout or Attach DTC: Physician Recharge - Antenna Too Hot
INS Charge Status	Audio key or system timeout or Attach DTC: INS Charge Status
INS Charge Status 90 to 100 %	Audio key or system timeout or Attach DTC: INS Charge Status - 90 to 100%
INS Charge Status - Antenna Too Hot	Audio key or system timeout or Attach DTC: INS Charge Status - Antenna Too Hot
Start Screen - Not Docked	Audio key or system timeout: Start Screen - Not Docked Attach DTC: INSR Charge Status

INS Battery Low Message - continued

Screen Entry: User Control / System Event

[0122] 

• Detach DTC

Entry Screen		User Control / System Event: Next Screen
-	INS Charge Status	-	Audio key or system timeout: previous screen
-	INS Charge Status - 90 to 100%	-	Therapy On/Off and telemetry success: previous screen with Therapy On/Off icon on status line (Table 17-22)
-	INS Charge Status - Antenna Too Hot	-	Therapy On/Off and telemetry event: Refer to Table 18
		-	Start Charge and antenna temperature OK: Wait Screen (Table 17-1)
		-	Start Charge and antenna too hot: INS Charge Status - Antenna Too Hot Screen (Table 17-13)
		-	Stop Charge: Start Screen - Not Docked
		-	Attach DTC: previous screen with power source symbol on status line (Table 17-23)
INSR Charge Status		-	Audio key or system timeout: Start Screen - Not Docked
		-	Therapy On/Off and telemetry success: Start Screen - Not Docked with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry event: Refer to Table 18
		-	Start Charge and antenna temperature OK: Wait Screen (Table 17-1)
		-	Start Charge and antenna too hot: Antenna Too Hot Message (Table 17-30)
		-	Stop Charge: no change
		-	Attach DTC: INSR Charge Status
-	Physician Recharge Screen	-	Audio key or system timeout: previous screen
		-	Therapy On/Off: no change
-	Physician Recharge - Antenna Too Hot	-	Start Charge: no change
		-	Stop Charge: Start Screen - Not Docked
		-	Attach DTC: previous screen

13- INSR Recharge Interrupted Message

Screen Entry: User Control / System Event

[0123] 

• Detach DTC

Entry Screen		User Control / System Event: Next Screen
-	INSR Charge Status	-	Audio key or system timeout: Start Screen - Not Docked
		-	Therapy On/Off and telemetry success: Start Screen - Not Docked with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry event: Refer to Table 18
		-	Start Charge and antenna temperature OK: Wait Screen (Table 17-1)
		-	Start Charge and antenna too hot: Antenna Too Hot Message (Table 17-30)
		-	Stop Charge: no change
		-	Attach DTC: INSR Charge Status

14- INSR Recharge Complete Message

Screen Entry: User Control / System Event

[0124] 

• INSR recharge complete

Entry Screen	User Control / System Event: Next Screen
INSR Charge Status	-	Audio key: Start Screen - Docked
	-	Therapy On/Off and telemetry success: Start Screen - Docked with Therapy On/Off icon on status line (Table 17-22)
	-	Therapy On/Off and telemetry event: Refer to Table 18
	-	Start Charge and antenna temperature OK: Wait Screen (Table 17-1)
	-	Start Charge and antenna too hot: Antenna Too Hot Message (Table 17-30)
	-	Stop Charge: no change
	-	Detach DTC: Start Screen - Not Docked

Screen Entry: User Control / System Event

[0125] 

• Attach DTC

Entry Screen		User Control / System Event: Next Screen
-	Power Down	-	Audio key: Start Screen - Docked
-	Start Screen - Not Docked	-	Therapy On/Off and telemetry success: Start Screen - Docked with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry event: Refer to Table 18
		-	Start Charge and antenna temperature OK: Wait Screen (Table 17-1)
		-	Start Charge and antenna too hot: Antenna Too Hot Message (Table 17-30)
		-	Stop Charge: no change
		-	Detach DTC: Start Screen - Not Docked

15- INSR System Information Message

Screen Entry: User Control / System Event

[0126] 

• Audio + Stop Charge

Entry Screen		User Control / System Event: Next Screen
-	Power Down	-	Audio key: Cycle through information
-	Start Screen - Not Docked	-	Stop Charge or System timeout and not docked: Start Screen - Not Docked
-	Start Screen - Docked	-	Stop Charge or System timeout and docked: Start Screen - Docked
		-	Therapy On/Off and telemetry success: Start Screen - Not Docked with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry event: Refer to Table 18
		-	Start Charge and antenna temperature OK: Wait Screen (Table 17-1)
		-	Start Charge and antenna too hot: Antenna Too Hot Message (Table 17-30)
		-	Attach/Detach DTC: no change

16- Call Your Doctor- ERI Message

Screen Entry: User Control / System Event

[0127] 

• Therapy On/Off

Entry Screen		User Control / System Event: Next Screen
-	Power Down	-	Audio key or system timeout: Start Screen - Not Docked with
-	Start Screen - Not Docked		Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry success: Start Screen - Not Docked with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry event: Refer to Table 18
		-	Start Charge and antenna temperature OK: Wait Screen (Table 17-1)
		-	Start Charge and antenna too hot: Antenna Too Hot Message (Table 17-30)
		-	Stop Charge/Attach DTC: no change
-	INS Charge Status	-	Audio key or system timeout: previous screen with Therapy On/Off icon on status line (Table 17-22)
-	INS Charge Status - 90 to 100%
		-	Therapy On/Off and telemetry success: previous screen with
-	INS Charge Status- Antenna Too Hot		Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry event: Refer to Table 18
		-	Start Charge and antenna temperature OK: Wait Screen (Table 17-1)
		-	Start Charge and antenna too hot: INS Charge Status - Antenna Too Hot Screen (Table 17-13)
		-	Stop Charge and not docked: Start Screen - Not Docked
		-	Stop Charge and docked: Start Screen - Docked
		-	Attach DTC/Detach DTC: no change
INSR Charge Status		-	Audio key or system timeout: INSR Charge Status Screen with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry success: INSR Charge Status with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry event: Refer to Table 18
		-	Start Charge and antenna temperature OK: Wait Screen (Table 17-1)
		-	Start Charge and antenna too hot: Antenna Too Hot Message (Table 17-30)
		-	Stop Charge/Detach DTC: no change
	Start Screen - Docked	-	Audio key or system timeout: Start Screen - Docked with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry success: Start Screen - Docked with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry event: Refer to Table 18
		-	Start Charge and antenna temperature OK: Wait Screen (Table 17-1)
		-	Start Charge and antenna too hot: Antenna Too Hot Message (Table 17-30)
		-	Stop Charge/Detach DTC: no change

Call Your Doctor - ERI continued

Screen Entry: User Control / System Event

[0128] 

• INS error: ERI

Entry Screen		User Control / System Event: Next Screen
Wait Screen		-	Audio key or system timeout: Wait Screen
		-	Therapy On/Off and telemetry success: Wait Screen
		-	Therapy On/Off and telemetry event: Refer to Table 18
		-	Start Charge and antenna temperature OK: Wait Screen (Table 17-1)
		-	Start Charge and antenna too hot: INS Charge Status - Antenna Too Hot Screen (Table 17-13)
		-	Stop Charge/Attach DTC/Detach DTC: no change
-	INS Charge Status	-	Audio key or system timeout: previous screen
-	INS Charge Status -90 to 100%	-	Therapy On/Off and telemetry success: previous screen with Therapy On/Off icon on status line (Table 17-22)
-	INS Charge Status- Antenna Too Hot	-	Therapy On/Off and telemetry event: Refer to Table 18
		-	Start Charge and antenna temperature OK: Wait Screen (Table 17-1)
		-	Start Charge and antenna too hot: INS Charge Status - Antenna Too Hot Screen (Table 17-13)
		-	Stop Charge and not docked: Start Screen - Not Docked
		-	Stop Charge and docked: Start Screen - Docked
		-	Attach DTC/Detach DTC: no change

17- Call Your Doctor- POR Message

Screen Entry: User Control / System Event

[0129] 

• Therapy On/Off

Entry Screen		User Control / System Event: Next Screen
-	Power Down	-	Audio key or system timeout: Start Screen - Not Docked with Therapy On/Off icon on status line (Table 17-22)
-	Start Screen - Not
	Docked	-	Therapy On/Off: no change
		-	Start Charge/Stop Charge/Attach DTC/Detach DTC: no change
-	INS Charge Status	-	Audio key or system timeout: previous screen with Therapy On/Off icon on status line (Table 17-22)
-	INS Charge Status - 90 to 100%
		-	Therapy On/Off: no change
-	INS Charge Status - Antenna Too Hot	-	Stop Charge and not docked: Start Screen - Not Docked
		-	Stop Charge and docked: Start Screen - Docked
		-	Start Charge/Attach DTC/Detach DTC: no change
	INSR Charge Status	-	Audio key or system timeout: INSR Charge Status Screen with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off: no change
		-	Start Charge/Stop Charge/Attach DTC/Detach DTC: no change
Start Screen - Docked		-	Audio key or system timeout: Start Screen - Docked with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off: no change
		-	Start Charge/Stop Charge/Attach DTC/Detach DTC: no change

Screen Entry: User Control / System Event

[0130] 

• INS error: POR

Entry Screen		User Control / System Event: Next Screen
Wait Screen		-	Audio key or system timeout: Wait Screen
		-	Therapy On/Off and telemetry success: Wait Screen
		-	Therapy On/Off and telemetry event: Refer to Table 18
		-	Start Charge and antenna temperature OK: Wait Screen (Table 17-1)
		-	Start Charge and antenna too hot: Antenna Too Hot Message (Table 17-30)
		-	Stop Charge/Attach DTC/Detach DTC: no change
-	INS Charge Status	-	Audio key or system timeout: previous screen
-	INS Charge Status - 90 to 100%INS	-	Therapy On/Off and telemetry success: previous screen with Therapy On/Off icon on status line (Table 17-22)
	Charge Status - Antenna Too Hot	-	Therapy On/Off and telemetry event: Refer to Table 18
		-	Stop Charge and not docked: Start Screen-Not Docked
		-	Stop Charge and docked: Start Screen - Docked
		-	Start Charge/Attach DTC/Detach DTC: no change

18- Antenna Too Hot Message

Screen Entry: User Control / System Event

[0131] 

• Start Charge

Entry Screen		User Control / System Event: Next Screen
-	Power Down	-	Audio key or system timeout and not docked and antenna too hot: Start Screen - Not Docked
-	Start Screen - Docked
		-	Audio key or system timeout and docked and antenna too hot: Start Screen - Docked
-	Start Screen - Not Docked
		-	Audio key or system timeout and docked/not docked and antenna cools: INS Charge Status/INS Charge Status - 90 to 100%
-	INSR Charge Status
-	INS Battery Low	-	Therapy On/Off and telemetry success and not docked: Start Screen - Not Docked with Therapy On/Off icon on status line (Table 17-22)
-	INS Recharge Interrupted
-	INS Recharge Complete	-	Therapy On/Off and telemetry success and docked: Start Screen - Docked with Therapy On/Off icon on status line (Table 17-22)
-	INSR Battery Low
-	INSR Recharge	-	Therapy On/Off and telemetry event: Refer to Table 18
	Interrupted	-	Start Charge: no change
-	INSR Recharge Complete	-	Stop Charge and charge complete: INS Recharge Complete Message (Table 17-6)
-	Call Your Doctor - ERI	-	Stop Charge and charge incomplete and not INS battery low: INS Recharge Interrupted Message (Table 17-5)
-	Call Your Doctor - POR Reposition Antenna - Press Start Charge Warning	-	Stop Charge and INS battery low: INS Battery Low Message (Table 17-3)
		-	Stop Charge and INS battery depleted: Recharge Stimulator Warning (Table 17-4)
		-	Attach/detach DTC: no change
-	Connect INSR Antenna

19- Warning Messages

[0132] 

Warning	User Control / System Event: Next Screen
Recharge Stimulator	-	Start Charge and antenna temperature OK: Wait Screen (Table 17-1)
	-	Start Charge and antenna too hot: Antenna Too Hot Message (Table 17-30)
	-	System timeout: Power Down
Recharge INSR	-	Attach DTC: INSR Charge Status Screen with Power Source Symbol
	-	System timeout: Power Down
Reposition Antenna - Press Start Charge	-	Start Charge and antenna temperature OK: Wait Screen (Table 17-1)
	-	Start Charge and antenna too hot: Antenna Too Hot Message (Table 17-30)
	-	System timeout: Power Down
Reposition Antenna - Press Therapy Off	-	Therapy Off and telemetry success: Start Screen - Docked or Start Screen - Not Docked with Therapy Off icon on status line (Table 17-22)
	-	Therapy Off and telemetry event: refer to Table 18
	-	System timeout: Power Down
Reposition Antenna - Press Therapy On	-	Therapy On and telemetry success: Start Screen - Docked or Start Screen - Not Docked with Therapy On icon on status line (Table 17-22)
	-	Therapy On and telemetry event: refer to Table 18
	-	System timeout: Power Down
Call Your Doctor	-	System timeout: Power Down
Call Your Doctor - EOS	-	System timeout: Power Down

20- Splash Screen

Screen Entry: User Control / System Event

[0133] 

• Application is loading
• Reset button is activated and application is reloading

Processing Requirements

[0134] 

• All keys active
• Software will display the screen until the user presses any key or the system times out.
• When the user presses any key or the system times out, software will display the Start Screen - Docked or Start Screen - Not Docked (Table 17-29)

21- Connect INSR Antenna Message

Screen Entry: User Control / System Event

[0135] 

• Antenna disconnected

Entry Screen		User Control / System Event: Next Screen (assuming antenna and recharger are making full contact)
-	Wait Screen	-	Audio key or system timeout and not docked: Start Screen - Not Docked
-	INS Charge Status Screen
		-	Audio key or system timeout and docked: Start Screen - Docked
-	INS Charge Status - 90 to 100%
		-	Therapy On/Off and telemetry success and not docked: Start Screen - Not Docked with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry success and docked: Start Screen - Docked with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry event: Refer to Table 18
		-	Start Charge and antenna temperature OK: Wait Screen (Table 17-1)
		-	Start Charge and antenna too hot: INS Charge Status - Antenna Too Hot Screen (Table 17-13)
		-	Stop Charge: no change
		-	Attach/detach DTC: no change
-	Physician Recharge Screen	-	Audio key or system timeout and not docked: Start Screen - Not Docked
-	Physician Recharge Screen - Antenna Too Hot	-	Audio key or system timeout and docked: Start Screen - Docked
		-	Therapy On/Off: no change
		-	Start Charge: no change
		-	Stop Charge: no change
		-	Attach/detach DTC: no change

Screen Entry: User Control / System Event

[0136] 

• Therapy On/Off
• Start Charge

Entry Screen		User Control / System Event: Next Screen (assuming antenna and recharger are making full contact)
-	All screens and messages with the exception of Physician Recharge Screen, Physician Recharge - Antenna Too Hot Screen, IR Communication Screen, Splash Screen and all reposition antenna warnings	-	Audio key or system timeout and not docked: Start Screen - Not Docked
		-	Audio key or system timeout and docked: Start Screen - Docked
		-	Therapy On/Off and telemetry success and not docked: Start Screen - Not Docked with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry success and docked: Start Screen - Docked with Therapy On/Off icon on status line (Table 17-22)
		-	Therapy On/Off and telemetry event: Refer to Table 18
		-	Start Charge and antenna temperature OK: Wait Screen (Table 17-1)
		-	Start Charge and antenna too hot: Antenna Too Hot Message (Table 17-30)
		-	Stop Charge: no change
		-	Attach/detach DTC: no change

22- INS Charge Status - 90 to 100 % Screen

Screen Entry: User Control / System Event

[0137] 

• System timeout or message clear
• Antenna temperature OK
• Battery voltage indicates 90%

User Control / System Event	System Response: Feedback / Next Screen (requirement)
Therapy On/Off	-	Telemetry success: Therapy On/Off icon on status line (Table 17-22)
	-	Telemetry event: refer to Table 18
Start Charge	-	Start Charge and antenna temperature OK: Wait Screen (Table 17-1)
	-	Start Charge and antenna too hot: INS Charge Status - Antenna Too Hot Screen (Table 17-13)
Stop Charge	-	INS Recharge Complete Message (Table 17-6)
Audio	-	Toggle Audio icon (Table 17-24)
Attach DTC	-	Power source symbol on status line (Table 17-23)
Detach DTC	-	INSR battery low: INSR Battery Low Message (Table 17-8)
	-	INSR battery depleted: Recharge INSR Warning (Table 17-9)
	-	Status line without power source symbol (Table 17-23)
INS recharge complete	-	INS Recharge Complete Message (Table 17-6)
INS error: ERI	-	Call Your Doctor ERI Message (Table 17-19)
INS error: POR	-	Call Your Doctor - POR Message (Table 17-27)
INS error: EOS, battery voltage too high	-	Call Your Doctor Warning (Table 17-18)
Antenna too hot	-	INS Charge Status - Antenna Too Hot (Table 17-13)
Antenna failure	-	Call Your Doctor Warning (Table 17-18)
Antenna disconnected	-	Connect INSR Antenna Message (Table 17-14)
INSR battery low	-	INSR Battery Low Message (Table 17-8)
INSR battery depleted	-	Recharge INSR Warning (Table 17-9)
INSR recharge complete	-	INSR Batt1 on status line (Table 17-25)
System error	-	Call Your Doctor Warning (Table 17-18)
Audio + Stop Charge	-	No change
Audio + Start Charge and hold for > 10 seconds	-	No change

23- INS Charge Status - Antenna Too Hot Screen

Screen Entry: User Control / System Event

[0138] 

• Antenna too hot
• System timeout or message clear

User Control / System Event	System Response: Feedback / Next Screen (requirement)
Therapy On/Off	-	Telemetry success: Therapy On/Off icon on status line (Table 17-22)
	-	Telemetry event: refer to Table 18
Start Charge	-	Start Charge and antenna temperature OK: Wait Screen (Table 17-1)
	-	Start Charge and antenna too hot: INS Charge Status - Antenna Too Hot Screen (Table 17-13)
Stop Charge	-	Not docked: Start Screen - Not Docked
	-	Docked and INSR recharge complete: INSR Recharge Complete Message (Table 17-11)
	-	Docked and INSR recharge incomplete: INSR Charge Status Screen (Table 17-7)
Audio	-	Toggle Audio icon (Table 17-24)
Attach DTC	-	Power source symbol on status line (Table 17-23)
Detach DTC	-	INSR battery low: INSR Battery Low Message (Table 17-8)
	-	INSR battery depleted: Recharge INSR Warning (Table 17-9)
	-	Status line without power source symbol (Table 17-23)
INS error: ERI	-	Call Your Doctor ERI Message (Table 17-19)
INS error: POR	-	Call Your Doctor - POR Message (Table 17-27)
INS error: EOS, battery voltage too high	-	Call Your Doctor Warning (Table 17-18)
Antenna too hot	-	INS Charge Status - Antenna Too Hot (Table 17-13)
Antenna cooled	-	Wait Screen/INS Charge Status (Table 17-1)
Antenna failure	-	Call Your Doctor Warning (Table 17-18)
Antenna disconnected	-	Connect INSR Antenna Message (Table 17-14)
INSR battery low	-	INSR Battery Low Message (Table 17-8)
INSR battery depleted	-	Recharge INSR Warning (Table 17-9)
INSR recharge complete	-	INSR Batt1 on status line (Table 17-25)
System error	-	Call Your Doctor Warning (Table 17-18)
Audio + Stop Charge	-	No change
Audio + Start Charge and hold for > 10 seconds	-	No change

24- Physician Recharge - Antenna Too Hot Screen

Screen Entry: User Control / System Event

[0139] 

• Antenna too hot

Table 18

User Control / System Event*	System Response: Feedback / Next Screen (requirement)
Successful communication with INS	-	INS Charge Status Screen (Table 17-2)
Timer goes to zero and system times out (not docked)	-	Start Screen - Not Docked without Therapy On/Off icon on status line (Table 17-22)
Timer goes to zero and system times out (docked)	-	INSR recharge incomplete: INSR Charge Status Screen (Table 17-7)
	-	INSR recharge complete: INSR Recharge Complete Message (Table 17-11)
Stop Charge (not docked)	-	Start Screen- Not Docked
Stop Charge (docked)	-	Start Screen - Docked
Detach DTC	-	INSR battery low: INSR Battery Low Message (Table 17-8) INSR battery depleted: Recharge INSR Warning (Table 17-9)
Antenna too hot	-	Physician Mode - Antenna Too Hot (Table 17-31)
Antenna failure	-	Call Your Doctor Warning (Table 17-18)
Antenna disconnected	-	Connect INSR Antenna Message (Table 17-14)
System error	-	Call Your Doctor Warning (Table 17-18)
INSR battery low	-	INSR Battery Low Message (Table 17-8)
INSR battery depleted	-	Recharge INSR Warning (Table 17-9)
INSR recharge complete	-	No change

*Note: all keys inactive except Stop Charge

1-	When the user presses start charge or the antenna has cooled, software will display the Wait Screen until successful communication with the INS is established..
2-	Software will display the INS Charge Status Screen as soon as successful communication with the INS is established.
3-	Display INS Battery Low Message
4-	Display Recharge Stimulator Warning
5-	Display INS Recharge Interrupted Message
6-	Display INS Recharge Complete Message
7-	Display INSR Charge Status Screen
8-	Display INSR Battery Low Message
9-	Display Recharge INSR Warning
10-	Display INSR Recharge Interrupted Message
11-	Display INSR Recharge Complete Message
12-	Display Reposition Antenna Press Start Charge Warning
13-	Display INS Charge Status - Antenna Too Hot Screen
14-	Display Connect INSR Antenna Message
15-	Display Reposition Antenna Press Therapy On Warning
16-	Display Reposition Antenna Press Therapy Off Warning
17-	Display INSR System Information Message
18-	Display Call Your Doctor Warning
19-	Display Call Your Doctor - ERI Message
20-	Entry intentionally left blank to preserve numbering
21-	Display Physician Recharge Screen
22-	Software will display an indicator for stimulation status (On/Off) on the status line.
23-	Software will display the power source symbol when the desktop charger is docked.
24-	Software will display an indicator for audio control on the status line.
25-	Software will display the INSR charge level on the status line.
26-	Software will update the recharge efficiency line each time user presses Start Charge.
27-	Display Call Your Doctor - POR Message
28-	Display IR Communication Screen
29-	Display Splash Screen
30-	Display Antenna Too Hot Message
31-	Display Physician Recharge - Antenna Too Hot Screen

Table 19 Therapy On/Off Events

	System Event	Next Screen (requirement)
1.	Telemetry failure for Therapy On	Reposition Antenna - Press Therapy On Warning (Table 17-15)
2.	Telemetry failure for Therapy Off	Reposition Antenna - Press Therapy Off Warning (Table 17-16)
3.	INS battery low	INS Battery Low Message (Table 17-3)
4.	INS battery depleted or in sleep mode	Recharge Stimulator Warning (Table 17-4)
5.	INS error - ERI	Call Your Doctor - ERI Message (Table 17-19)
6.	INS error - POR	Call Your Doctor - POR Message (Table 17-27)
7.	INS error - EOS or battery voltage too high	Call Your Doctor Warning (Table 17-18)
8.	INSR battery low	INSR Battery Low Message (Table 17-8)
9.	INSR battery depleted	Recharge INSR Warning (Table 17-9)
10.	Antenna failure	Call Your Doctor Warning (Table 17-18)
11.	Antenna disconnected	Connect INSR Antenna Message (Table 17-14)
12.	System error	Call Your Doctor Warning (Table 17-18)
13.	Antenna too hot	Display INS Charge Status - Antenna Too Hot Screen (Table 17-13) or Antenna Too Hot Message (Table 17-30)

[0140] User familiarity with both external programming unit 2 and charging unit 50 is enhanced through the use of common patient controls and/or display icons across both devices. The user is presented with common controls and displays across both platforms.

[0141] The primary purpose of external programming unit 2 is to manipulate therapeutic programs such as starting therapy and stopping therapy. The primary purpose of charging unit 50 is to charge or recharge rechargeable power source 24. However, patients may want to control their therapy while charging unit 50 is charging the rechargeable power source 24 of implantable medical device 16. Thus, charging unit 50 is also equipped with controls to start and stop therapy as well as controls to start and stop charging.

[0142] External programming unit 2 and charging unit 50 both have similar "Therapy On" controls as illustrated in Table 1 and Table 11, respectively. Similarly, both external programming unit 2 and charging unit 50 also have similar "Therapy Off" controls as illustrated in Table 1 and Table 11, respectively.

[0143] To aid in familiarity by the user, both external programming unit 2 and charging unit 50 also have similar or identical icons to display the same or similar messages to the user. Battery charging level icons "INSR Batt 1", "INSR Batt 2", "INSR Batt 3", "INSR Batt 4" and "INSR Batt 5" icons are similar or identical between external programming unit 2 and charging unit 50 as illustrated in Table 1 and Table 11, respectively.

[0144] Similarly, the "Call Doctor" icon illustrated in Table 5 with respect to external programming unit 2 is the same as, or very nearly the same as, the "Call Doctor" icon illustrated in Table 15 with respect to charging unit 50.

[0145] The "Warnings" icon illustrated in Table 5 with respect to external programming unit 2 is the same as, or very nearly the same as, the "Warnings" icon illustrated in Table 16 with respect to charging unit 50.

[0146] "Audio On" and "Audio Off" icons illustrated in Table 6 with respect to external programming unit 2 are the same as, or very nearly the same as, the "Audio On" and "Audio Off" icons illustrated in Table 11 with respect to charging unit 50.

[0147] These are examples of controls and icons that are the same, or very similar, between both platforms, the external programming unit 2 and the charging unit 50 to aid in user familiarity.

[0148] As noted with respect to Figure 17 describing the process of charging rechargeable power source 24 using external charging device 48, charging unit 50 receives information via telemetry from implantable medical device 16 during the charging process. External antenna 52 contains both primary coil 54 and external telemetry coil 46 and implantable medical device 16 contains both secondary coil 34 and internal telemetry coil 44. When external antenna 52 is positioned properly at or near the site of implantable medical device 16, primary coil 54 can be inductively coupled to secondary coil 34 to facilitate the charging process. Similarly, external telemetry coil 46 can be coupled with internal telemetry coil 44 to communicate information across cutaneous boundary 38 during the charging process.

[0149] Also as noted above, magnetic shield 36 prevents electromagnetic radiation stimulating secondary coil 34 from reaching the interior of housing 32 of implantable medical device. However, external telemetry coil 46 and internal telemetry coil 44 are sized to be larger than magnetic shield 36 allowing electromagnetic communication between external telemetry coil 46 and internal telemetry coil 44.

[0150] At step 112 of the charging process illustrated in Figure 17, a check is made to determine if telemetry is occurring between charging unit 50 and implantable medical device 16. Further, the status of charging rechargeable power source 24 is communicated from implantable medical device 16 and displayed by charging unit 50 (step 118). The charging status displayed by charging unit 50 can be the actual known charging status of rechargeable power source 24 as communicated from implantable medical device 16 to charging unit 50. This prevents essentially guessing the internal charging status of rechargeable power source 24 by some external means such as simply by the passage of time. Rather, the actual charging status of rechargeable power source 24, e.g., the battery voltage, can be measured and transmitted to charging unit 50 for display to the user.

[0151] Typically, inductive charging and telemetry operations are time division multiplexed during the charging operation. That is, a portion of the time during which charging occurs is dedicated to telemetry. During this dedicated telemetry time, the inductive charging by primary coil 54 to secondary coil 34 is momentarily stopped and telemetry allowed to occur. As soon as telemetry has occurred and the required information has been communicated, inductive coupling can be resumed. Typically, only a relatively small portion of the time period during charging is required to be devoted to telemetry. Inductive charging can be stopped only for a short time, e.g., a few seconds, to allow for telemetry and then inductive charging can be resumed. Although the time division multiplexing occurs over the entire charging period, only a small portion of the charging time is lost to telemetry. Time division multiplexing of inductive coupling charging and telemetry prevents the possibility of inductive charging from interfering with telemetry signals.

Claims

1. An implantable medical device system, comprising:

an implantable medical device (16) for providing a therapeutic output to a patient ; said implantable medical device (16) being capable of communication with an external patient control unit (2) allowing said patient to control said therapeutic output of said implantable medical device (16)

an external patient control unit (2) adapted to be operatively coupled via telemetry with said implantable medical device (16) allowing said patient to control said therapeutic output of said implantable medical device said external patient control unit (2) having a first housing and a first user interface operable by said patient having patient controls and display icons indicative of a status of operation of said patient control unit (2); and

an external energy transfer unit (48) having a second housing hand being adapted to transcutaneously transfer energy to the implantable medical device (16) for providing the therapeutic output to a patient, and characterized by said external energy transfer unit comprising:

a second user interface operable by said patient having patient controls and display icons indicative of a status of operation of said energy transfer unit (48);

at least some of said patient controls and said display icons of said energy transfer unit (48) being common with at least some of said patient controls and said display icons of said patient control unit (2).

2. A system as claimed in claim 1, comprising fewer than three operative controls to control energy transfer from said external energy transfer unit (48) to said implantable medical device (16).

3. The system of claim 1, wherein said implantable medical device (16) is capable of receiving inductively coupled energy with a secondary coil (34) and is capable of being transcutaneously controlled using an internal telemetry coil (44); said system further comprising:

an external antenna (52) having a primary coil (54) adapted to inductively transfer energy to a secondary coil (34) of said implantable medical device (16) when said external antenna (52) is externally placed in proximity of said secondary coil (34); and wherein

said external energy transfer unit (48) is adapted to be operatively coupled by a cord to said external antenna (52) driving said primary coil (54) to inductively transfer energy to said implantable medical device (16);

said energy transfer unit (48) having an external telemetry coil (46) allowing said energy transfer unit (48) to communicate with said implantable medical device (16) through said internal telemetry coil (44) in order to at least partially control said therapeutic output of said implantable medical device (16).

4. A system as claim 1, wherein at least one of said display icons comprises an icon representative of a state of charging of an energy storage device in said implantable medical device (16).

5. A system as in any preceding claim wherein at least one of said patient controls comprises a control for adjusting said therapeutic output of said implantable medical device (16).

6. A system as in any of claims 1 to 4 wherein said external energy transfer unit (48) inductively couples energy to said implantable medical device (16).

7. A system as in any of claims 1 to 4 wherein said implantable medical device (16) has a rechargeable energy storage device and wherein said energy transfer unit (48) charges said rechargeable energy storage device.

8. A system as in claim 1 wherein said energy transfer unit (48) is operable with two operative controls to control energy transfer from said external energy transfer unit (48) to said implantable medical device (16).

9. A system as in claim 8 wherein said two operative controls comprise a start control and a stop control

10. A system as in any of claims 8 or 9 wherein said energy transfer unit (48) further comprises operative controls to start and stop said therapeutic output of said implantable medical device (16).

11. A system as in any of claims 8 or 9 wherein said external energy transfer unit (48) inductively couples energy to said implantable medical device (16).

12. A system as in any of claims 8 or 9 wherein said implantable medical device (16) has a rechargeable energy storage device and wherein said energy transfer unit (48) charges said rechargeable energy storage device.

Ansprüche

1. System einer implantierbaren medizinischen Vorrichtung, das enthält:

eine implantierbare medizinische Vorrichtung (16) zum Bereitstellen einer therapeutischen Ausgabe für einen Patienten, wobei die implantierbare medizinische Vorrichtung (16) mit einer äußeren Patientensteuereinheit (2) kommunizieren kann, was dem Patienten erlaubt, die therapeutische Ausgabe der implantierbaren medizinischen Vorrichtung (16) zu steuern;

eine äußere Patientensteuereinheit (2), die beschaffen ist, um über Telemetrie mit der implantierbaren medizinischen Vorrichtung (16) betriebsfähig gekoppelt zu sein, was dem Patienten erlaubt, die therapeutische Ausgabe der implantierbaren medizinischen Vorrichtung zu steuern, wobei die äußere Patientensteuereinheit (2) ein erstes Gehäuse und eine erste Benutzerschnittstelle besitzt, die durch den Patienten betreibbar ist und die Patienten-Steuerungen und Anzeige-Piktogramme, die den zustand des Betriebs der Patientensteuereinheit (2) anzeigen, besitzt; und

eine äußere Energieübertragungseinheit (48), die ein zweites Gehäuse besitzt und beschaffen ist, um Energie transkutan zu der implantierbaren medizinischen Vorrichtung (16) zum Bereitstellen der therapeutischen Ausgabe für einen Patienten zu übertragen,

dadurch gekennzeichnet, dass die äußere Energieübertragungseinheit umfasst:

eine zweite Benutzerschnittstelle, die durch den Patienten betreibbar ist und die Patienten-Steuerungen und Anzeige-Piktogramme, die den Zustand des Betriebs der Energieübertragungseinheit (48) anzeigen, besitzt;

wobei wenigstens einige der Patienten-Steuerungen und Anzeige-Piktogramme der Energieübertragungseinheit (48) mit wenigstens einigen der Patienten-Steuerungen und Anzeige-Piktogramme der Patientensteuereinheit (2) gemeinsam sind.

2. System nach Anspruch 1, das weniger als drei betriebsfähige Steuerungen umfasst, um die Energieübertragung von der äußeren Energieübertragungseinheit (48) zu der implantierbaren medizinischen Vorrichtung (16) zu steuern.

3. System nach Anspruch 1, wobei die implantierbare medizinische Vorrichtung (16) induktiv gekoppelte Energie mit einer Sekundärspule (34) empfangen kann und unter Verwendung einer inneren Telemetriespule (44) transkutan gesteuert werden kann; wobei das System ferner umfasst:

eine äußere Antenne (52), die eine Primärspule (54) besitzt, die beschaffen ist, um Energie zu einer Sekundärspule (34) der implantierbaren medizinischen Vorrichtung (16) induktiv zu übertragen, wobei die äußere Antenne (52) in der Nähe der Sekundärspule (34) außen angeordnet ist; und wobei

die äußere Energieübertragungseinheit (48) beschaffen ist, um durch ein Kabel an die äußere Antenne (52) betriebsfähig gekoppelt zu sein und die Primärspule (54) anzutreiben, um induktiv Energie zu der implantierbaren medizinischen Vorrichtung (16) zu übertragen;

die Energieübertragungseinheit (48) eine äußere Telemetriespule (46) besitzt, was es der Energieübertragungseinheit (48) erlaubt, durch die innere Telemetriespule (44) mit der implantierbaren medizinischen Vorrichtung (16) zu kommunizieren, um die therapeutische Ausgabe der implantierbaren medizinischen Vorrichtung (16) wenigstens teilweise zu steuern.

4. System nach Anspruch 1, wobei das wenigstens eine der Anzeige-Piktogramme ein Piktogramm umfasst, das einen Zustand des Ladens einer Energiespeichervorrichtung in der implantierbaren medizinischen Vorrichtung (16) repräsentiert.

5. System nach einem vorhergehenden Anspruch, wobei wenigstens eine der Patientensteuerungen eine Steuerung zum Einstellen der therapeutischen Ausgabe der implantierbaren medizinischen Vorrichtung (16) umfasst.

6. System nach einem der Ansprüche 1 bis 4, wobei die äußere Energieübertragungseinheit (48) Energie an die implantierbare medizinische Vorrichtung (16) induktiv koppelt.

7. System nach einem der Ansprüche 1 bis 4, wobei die implantierbare medizinische Vorrichtung (16) eine wiederaufladbare Energiespeichervorrichtung besitzt und wobei die Energieübertragungseinheit (48) die wiederaufladbare Energiespeichervorrichtung lädt.

8. System nach Anspruch 1, wobei die Energieübertragungseinheit (48) mit zwei betriebsfähigen Steuerungen betreibbar ist, um die Energieübertragung von der äußeren Energieübertragungseinheit (48) zu der implantierbaren medizinischen Vorrichtung (16) zu steuern.

9. System nach Anspruch 8, wobei die zwei betriebsfähigen Steuerungen eine Startsteuerung und eine Stoppsteuerung umfassen.

10. System nach einem der Ansprüche 8 oder 9, wobei die Energieübertragungseinheit (48) ferner betriebsfähige Steuerungen umfasst, um die therapeutische Ausgabe der implantierbaren medizinischen Vorrichtung (16) zu starten und zu stoppen.

11. System nach einem der Ansprüche 8 oder 9, wobei die äußere Energieübertragungseinheit (48) die Energie induktiv an die implantierbare medizinische Vorrichtung (16) koppelt.

12. System nach einem der Ansprüche 8 oder 9, wobei die implantierbare medizinische Vorrichtung (16) eine wiederaufladbare Energiespeichervorrichtung besitzt und wobei die Energieübertragungseinheit (48) die wiederaufladbare Energiespeichervorrichtung lädt.

Revendications

1. Système de dispositif médical implantable, comportant :

un dispositif médical implantable (16) pour délivrer une sortie thérapeutique à un patient, ledit dispositif médical implantable (16) pouvant communiquer avec une unité de commande du patient externe (2) permettant audit patient de commander ladite sortie thérapeutique dudit dispositif médical implantable (16) ;

une unité de commande du patient externe (2) adaptée pour être couplée de manière opérationnelle par télémesure audit dispositif médical implantable (16) permettant audit patient de commander ladite sortie thérapeutique dudit dispositif médical implantable et étant ladite unité de commande de passion externe (2) ayant un premier boîtier et une première interface d'utilisateur actionnable par ledit patient ayant des commandes de patient et des icônes d'affichage indicatives d'un état de fonctionnement de ladite unité de commande du patient (2) ; et

une unité de transfert d'énergie externe (48) ayant un second boîtier adapté pour un transfert d'énergie de manière transcutanée vers le dispositif médical implantable (16) afin de délivrer la sortie thérapeutique à un patient ; et

charactérisé en ce que ladite unité de transfert d'énergie externe comporte :

une seconde interface d'utilisateur actionnable par ledit patient ayant des commandes de patient et des icônes d'affichage indicatives d'un état de fonctionnement de ladite unité de transfert d'énergie (48) ;

au moins certaines desdites commandes du patient et desdites icônes d'affichage de ladite unité de transfert d'énergie (48) étant communes avec au moins certaines desdites commandes du patient et desdites icônes d'affichage de ladite unité de commande du patient (2).

2. Système selon la revendication 1, comportant moins de trois commandes opérationnelles pour commander un transfert d'énergie depuis ladite unité de transfert d'énergie externe (48) vers ledit dispositif médical implantable (16).

3. Système selon la revendication 1, dans lequel ledit dispositif médical implantable (16) est capable de recevoir de l'énergie couplée de manière inductive à une bobine secondaire (34) et est capable d'être commandé de manière transcutanée en utilisant une bobine de télémesure interne (44) ; ledit système comportant en outre :

une antenne externe (52) ayant une bobine principale (54) adaptée pour transférer de manière inductive de l'énergie vers une bobine secondaire (34) dudit dispositif médical implantable (16) lorsque ladite antenne externe (52) est placée en externe à proximité de ladite bobine secondaire (34) ; et dans lequel

ladite unité de transfert d'énergie externe (48) est adaptée pour être couplée de manière opérationnelle par l'intermédiaire d'un cordon à ladite antenne externe (52) entraînant ladite bobine principale (54) pour transférer de manière inductive de l'énergie vers ledit dispositif médical implantable (16) ;

ladite unité de transfert d'énergie (48) ayant une bobine de télémesure externe (46) permettant à ladite unité de transfert d'énergie (48) de communiquer avec ledit dispositif médical implantable (16) via ladite bobine de télémesure interne (44) afin de commander au moins partiellement ladite sortie thérapeutique dudit dispositif médical implantable (16).

4. Système selon la revendication 1, dans lequel au moins l'une desdites icônes d'affichage comporte une icône représentative d'un état de chargement d'un dispositif de stockage d'énergie dans ledit dispositif médical implantable (16).

5. Système selon l'une quelconque des revendications précédentes, dans lequel au moins l'une desdites commandes du patient comporte une commande pour régler ladite sortie thérapeutique dudit dispositif médical implantable (16).

6. Système selon l'une quelconque des revendications 1 à 4, dans lequel ladite unité de transfert d'énergie externe (48) couple de manière inductive l'énergie audit dispositif médical implantable (16).

7. Système selon l'une quelconque des revendications 1 à 4, dans lequel ledit dispositif médical implantable (16) a un dispositif de stockage d'énergie rechargeable et dans lequel ladite unité de transfert d'énergie (48) charge ledit dispositif de stockage d'énergie rechargeable.

8. Système selon la revendication 1, dans lequel ladite unité de transfert d'énergie (48) fonctionne avec deux commandes opérationnelles pour commander un transfert d'énergie de commande depuis ladite unité de transfert d'énergie externe (48) vers ledit dispositif médical implantable (16).

9. Système selon la revendication 8, dans lequel deux commandes de fonctionnement comportent une commande de démarrage et une commande d'arrêt.

10. Système selon l'une quelconque des revendications 8 ou 9, dans lequel ladite unité de transfert d'énergie (48) comporte en outre des commandes opérationnelles pour démarrer et arrêter ladite sortie thérapeutique dudit dispositif médical implantable (16).

11. Système selon l'une quelconque des revendications 8 ou 9, dans lequel ladite unité de transfert d'énergie externe (48) couple de manière inductive l'énergie audit dispositif médical implantable (16).

12. Système selon l'une quelconque des revendications 8 ou 9, dans lequel ledit dispositif médical implantable (16) a un dispositif de stockage d'énergie rechargeable et dans lequel ladite unité de transfert d'énergie (48) charge ledit dispositif de stockage d'énergie rechargeable.

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